chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Afterwards headaches, body aches, fevers, cough, diarrhea.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient reported she developed hives a few days after receiving the flu shot. It started at her back as a big patch and spread throughout her body. It eventually spread from the back of the neck to her feet. The hives were worse at the sides and back.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient developed a bruise that spanned across the outer area of the left upper arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Injection site urticaria, Pruritus, Skin warm
Clinical narrative: Initial swelling; tired; napped; woke up with increased swelling, red, warm to touch; middle of the night woke up and it was redder, more swollen & itchy; by the time I got to work it was a bright red, very warm to the touch, quite itchy -- welt was 9 inches long & 3 1/2 inches at the widest point and began about a half inch beneath the injection and extended to my elbow.  When I got home that evening my husband took a picture and that was emailed to my doctor.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Initial swelling; tired; napped; woke up with increased swelling, red, warm to touch; middle of the night woke up and it was redder, more swollen & itchy; by the time I got to work it was a bright red, very warm to the touch, quite itchy -- welt was 9 inches long & 3 1/2 inches at the widest point and began about a half inch beneath the injection and extended to my elbow.  When I got home that evening my husband took a picture and that was emailed to my doctor.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient's wife states patient woke up 10/16/2017 and is having a hard time moving his left arm and it is painful at the injection site from his immunization he received on 09/29/2017.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose decreased, Chills, Diarrhoea, Fatigue, Haemoglobin normal
Clinical narrative: The patient went to Student Health urgent care on 10/09/2017. Per pt. after 2 hours of receiving the vaccines, he started to feel the symptoms of a headache, fatigue, and chills. After 3 days of receiving the vaccine, the patient started to have diarrhea.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: The patient went to Student Health urgent care on 10/09/2017. Per pt. after 2 hours of receiving the vaccines, he started to feel the symptoms of a headache, fatigue, and chills. After 3 days of receiving the vaccine, the patient started to have diarrhea.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The day after patient received the vaccine he developed a red, raised swollen spot on his right thigh. Mother called and sent photos of leg to PCP. Patient was advised to be seen at an urgent care clinic. PCP then consulted with infectious disease on how to proceed. PCP was advised to have patient seen by Allergist/Immunologist to see if patient is allergic to something in the vaccines or something that is used in prep and admin of the vaccine.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's right arm from shoulder to elbow was swollen, red and warm to the touch.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Muscle pain both arms, back, neck, left leg starting 2 days after immunization.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: Itching all over, whole body. Still itching after one week. Using oral BENADRYL and BENADRYL gel. After one week still itching some when the BENADRYL wears off.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Discomfort, Injection site pain, Mobility decreased, Muscle tightness
Clinical narrative: Injection give very high and anterior, above typical deltoid site. Injection itself was very painful (first time in 30+years). Progressive pain at injection site, radiating to above elbow, upper left back, shoulder, and left neck. Tingling into fingers. Within 6 hours was painful to raise arm above 90 degrees, if moved arm across my body, was not able to lift/hold parallel to the floor. Used heat, ibuprofen. 2 1/2 weeks later still have tenderness to touch at injection site and into upper back. Chronic ache does not go away unless I take ibuprofen. Due to discomfort, and some weakness reaching across body, I am overusing other muscles, discomfort and muscle tightness left upper back. Still have occasional tingling to left 3rd and 4th fingers.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Paraesthesia, Tenderness
Clinical narrative: Injection give very high and anterior, above typical deltoid site. Injection itself was very painful (first time in 30+years). Progressive pain at injection site, radiating to above elbow, upper left back, shoulder, and left neck. Tingling into fingers. Within 6 hours was painful to raise arm above 90 degrees, if moved arm across my body, was not able to lift/hold parallel to the floor. Used heat, ibuprofen. 2 1/2 weeks later still have tenderness to touch at injection site and into upper back. Chronic ache does not go away unless I take ibuprofen. Due to discomfort, and some weakness reaching across body, I am overusing other muscles, discomfort and muscle tightness left upper back. Still have occasional tingling to left 3rd and 4th fingers.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Head injury, Loss of consciousness
Clinical narrative: This initial spontaneous report was received from a Nurse Practitioner (NP) via a company representative and refers to a patient of unknown age and gender. Medical history and concurrent medications were not provided. In August 2017 (reported as about two months ago), the patient was vaccinated with GARDASIL 9 (dose and route not provided.)  It was unknown which dose in the series the patient received. While waiting at the office 15 minutes after receiving the vaccine, the patient passed out and hit their head. It was noted that two other patients also passed out after receiving the vaccine (see case # 1710USA007830). Two of the three injections came from the same lot # (lot # not provided). The patient went to the Emergency Room. It was unknown if hospitalization ensued. The outcome of the events were unknown. The NP did not provide causality assessment. The NP stated that a lawyer has contacted their office for this patient. Upon internal review, passed out was considered medically significant. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1710USA007830:
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Skin warm, Throat tightness
Clinical narrative: My daughter experienced an allergic reaction to the flu shot at school on Friday, October 13, just before 2 pm after receiving the flu shot at school at approximately 1:45pm. She had hives all over her left arm; her left arm was red, swollen, and hot to the touch; her left leg was red and hot to the touch; and most significantly, her throat was tight. School staff administered an EpiPen after my daughter told them her throat felt tight. EMS were called immediately thereafter. The school nurse gave my daughter 25 mg of Benadryl with my permission, and the paramedics told me to either take her to the hospital or to our doctor, so we went directly from school to our pediatrician. Our pediatrician was concerned that we might have to go to the hospital because when the EpiPen wears off, the allergic reaction can resume. Our pediatrician consulted another pediatrician, as well as an allergist. The allergist thought that my daughter most likely reacted to the preservative in the flu shot, and all three doctors concluded that we could stay in the office until they closed, so our physician could monitor my daughter's condition while the epinephrine wore off. My daughter was told to continue taking Benadryl and was prescribed prednisone for three days, along with additional EpiPens in case the reaction were to resume. Our pediatrician told us that my daughter can never have a flu shot again.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: My daughter experienced an allergic reaction to the flu shot at school on Friday, October 13, just before 2 pm after receiving the flu shot at school at approximately 1:45pm. She had hives all over her left arm; her left arm was red, swollen, and hot to the touch; her left leg was red and hot to the touch; and most significantly, her throat was tight. School staff administered an EpiPen after my daughter told them her throat felt tight. EMS were called immediately thereafter. The school nurse gave my daughter 25 mg of Benadryl with my permission, and the paramedics told me to either take her to the hospital or to our doctor, so we went directly from school to our pediatrician. Our pediatrician was concerned that we might have to go to the hospital because when the EpiPen wears off, the allergic reaction can resume. Our pediatrician consulted another pediatrician, as well as an allergist. The allergist thought that my daughter most likely reacted to the preservative in the flu shot, and all three doctors concluded that we could stay in the office until they closed, so our physician could monitor my daughter's condition while the epinephrine wore off. My daughter was told to continue taking Benadryl and was prescribed prednisone for three days, along with additional EpiPens in case the reaction were to resume. Our pediatrician told us that my daughter can never have a flu shot again.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: About 1 hr. after vaccination started low grade fever, chills, and headache, improved with TYLENOL. About 1.5 days after vaccination had headache, shoulder pain on right followed by swelling and painful swollen glands on clavicle (went to employee health and treated with ibuprofen). About 6 days after the shot I got swollen glands in my neck only on right side. As of 12 days since shot I still have swollen glands in my neck and clavicle, still some swelling over clavicle, and a headache that may or may not be related to the shot.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: About 1 hr. after vaccination started low grade fever, chills, and headache, improved with TYLENOL. About 1.5 days after vaccination had headache, shoulder pain on right followed by swelling and painful swollen glands on clavicle (went to employee health and treated with ibuprofen). About 6 days after the shot I got swollen glands in my neck only on right side. As of 12 days since shot I still have swollen glands in my neck and clavicle, still some swelling over clavicle, and a headache that may or may not be related to the shot.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient has been having itchiness on her palms, feet and groin area.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, pain of R upper arm. Fever of 102 x 3 days.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Feeling abnormal, Immediate post-injection reaction, Injection site nodule, Paraesthesia oral
Clinical narrative: Knot develop immediately after injection given left deltoid. 2 hours later came to Employee Health and reports throat feels like it is swelling, tongue feels heavy, chest is tight, and feels funny from chest up. Denies shortness of breath. BP 150/92 Pulse 71 O2 sat 98.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Pharyngeal oedema
Clinical narrative: Knot develop immediately after injection given left deltoid. 2 hours later came to Employee Health and reports throat feels like it is swelling, tongue feels heavy, chest is tight, and feels funny from chest up. Denies shortness of breath. BP 150/92 Pulse 71 O2 sat 98.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reports her right arm as red, very swollen, and very painful (describing as too painful to touch her arm). She said it is warm to touch.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Electrocardiogram abnormal, Headache, Sinus bradycardia, Vaccination complication
Clinical narrative: I am not exactly sure what brand/strain of the influenza vaccine I received, but the lot # was 222FX. After receiving the influenza vaccine on Monday October 9, I began having an adverse reaction to the vaccine on Wednesday, October 11 and continue to experience these symptoms. (The symptoms I am about to describe are all symptoms that I experienced last year after receiving the influenza vaccine at Medical Center (MC). The symptoms include headache, neck pain, sub sternal chest pain, chest tightness, decreased appetite, nausea, abdominal pain. After experiencing these symptoms last year, I was seen at the ER at MC and received the following diagnostic testing procedures: complete blood panel, 12 lead EKG, chest X-ray, head CT MRI of the brain, spinal tap. All test and procedures were inconclusive. As a result of the initial spinal tap, I developed a CSF leak and had 2 blood patches to treat spinal headaches I was experiencing.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Malaise, Muscle tightness, Musculoskeletal pain
Clinical narrative: About 3 days after receiving the shot I began feeling tired and under the weather so to speak. I began feeling really tired, and unmotivated and assumed I was coming down with some sort of illness and tried to rest as much as possible. After the weekend following my shot I asked the nurse who gave me the shot, and he said that was pretty normal and that it should go away in a few days. About 7 days after the shot, I started to have slight pain in my right shoulder, trapezius, and neck area. Sort of felt like I had slept on it wrong, but each day it kept getting worse. On October 14th, I finally decided that what was going on wasn't getting better with time and by this point I was in severe pain. Previously it was more with movement that would cause the pain, and now it was constant. It also left a spot on my upper left forehead near my temple sensitive to pressure. After visiting with my doctor, it was determined that I had some sort of reaction to the flu shot that I was given that was causing my lymph nodes to be swollen and sore. Which in-turn caused muscle aches alone my trapezius area, and my right neck. It is also believed that the tension in my neck is causing the spot on my left temple to possibly be tense as well from the neck muscle issues. I've been prescribed an antibiotic and muscle relaxant. As of two days after treatment, things don't seem to be that much better, however, I'm hopeful things will turn around.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: About 3 days after receiving the shot I began feeling tired and under the weather so to speak. I began feeling really tired, and unmotivated and assumed I was coming down with some sort of illness and tried to rest as much as possible. After the weekend following my shot I asked the nurse who gave me the shot, and he said that was pretty normal and that it should go away in a few days. About 7 days after the shot, I started to have slight pain in my right shoulder, trapezius, and neck area. Sort of felt like I had slept on it wrong, but each day it kept getting worse. On October 14th, I finally decided that what was going on wasn't getting better with time and by this point I was in severe pain. Previously it was more with movement that would cause the pain, and now it was constant. It also left a spot on my upper left forehead near my temple sensitive to pressure. After visiting with my doctor, it was determined that I had some sort of reaction to the flu shot that I was given that was causing my lymph nodes to be swollen and sore. Which in-turn caused muscle aches alone my trapezius area, and my right neck. It is also believed that the tension in my neck is causing the spot on my left temple to possibly be tense as well from the neck muscle issues. I've been prescribed an antibiotic and muscle relaxant. As of two days after treatment, things don't seem to be that much better, however, I'm hopeful things will turn around.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site bruising, Pyrexia, Throat irritation
Clinical narrative: 10-ish minutes after injection, patient noted throat was itchy and lasted about 15-20 minutes and then went away. And then after started feeling flushed and feverish. No meds were taken. Felt better once patient was leaving for day around 4pm. Then next day bruise appeared on injection site. Bruise lasted 11 days. Nothing further since those symptoms.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chromaturia, Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: Patient claims she got swollen lymph nodes, tender/swollen arm, body aches-hips, fever at 101 degrees F, and dark urine after getting the vaccinations.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Patient claims she got swollen lymph nodes, tender/swollen arm, body aches-hips, fever at 101 degrees F, and dark urine after getting the vaccinations.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Malaise
Clinical narrative: Patient had temp of 102 degrees Fahrenheit and malaise for about 24 hours.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cervical radiculopathy, Chest X-ray normal, Condition aggravated, Electrocardiogram normal, Full blood count normal
Clinical narrative: 1 week after receiving the flu shot in my left arm, I developed a mild throbbing intermediate pain radiating from area of shot down outer lateral arm to elbow. Occasional slightly painful to touch. I also had a mild outbreak of my cold sore require use of acyclovir ointment on my lip. The following week 9/24-9/30 it continued to bother me. I am left handed and had no change in ROM or difficult moving my arm but it bothered me while awake and more in a sitting position. I did take some sick time on Friday due to the discomfort in my arm not improving. See next page.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Laboratory test, Limb discomfort, Loss of personal independence in daily activities, Oral herpes
Clinical narrative: 1 week after receiving the flu shot in my left arm, I developed a mild throbbing intermediate pain radiating from area of shot down outer lateral arm to elbow. Occasional slightly painful to touch. I also had a mild outbreak of my cold sore require use of acyclovir ointment on my lip. The following week 9/24-9/30 it continued to bother me. I am left handed and had no change in ROM or difficult moving my arm but it bothered me while awake and more in a sitting position. I did take some sick time on Friday due to the discomfort in my arm not improving. See next page.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: 1 week after receiving the flu shot in my left arm, I developed a mild throbbing intermediate pain radiating from area of shot down outer lateral arm to elbow. Occasional slightly painful to touch. I also had a mild outbreak of my cold sore require use of acyclovir ointment on my lip. The following week 9/24-9/30 it continued to bother me. I am left handed and had no change in ROM or difficult moving my arm but it bothered me while awake and more in a sitting position. I did take some sick time on Friday due to the discomfort in my arm not improving. See next page.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome with Critical Care Admission.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Dizziness, Headache
Clinical narrative: 10/10 - extreme body ache/joint paint/fever/diarrhea/vomiting/loss of appetite/headache/dizziness. These symptoms lasted through 10/14. On 10/15, I broke out in a full body rash that covered everything except for the palms of my hands and soles of my feet.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash generalised, Vomiting
Clinical narrative: 10/10 - extreme body ache/joint paint/fever/diarrhea/vomiting/loss of appetite/headache/dizziness. These symptoms lasted through 10/14. On 10/15, I broke out in a full body rash that covered everything except for the palms of my hands and soles of my feet.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Face feels warm. Lt arm red, swollen, painful and itching. Also left leg itching and painful. Took Benadryl for symptoms x 2 days. All symptoms now resolved.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Md's office reported 10/12/17 9:40 am about pt's adverse reactions (redness and swelling) to PNEUMOVAX 23 given at our pharmacy on 10/10/17 and instructed pt to contact the pharmacy to provide more details. Spoke to pt on 10/15/17 5:30pm who reported she had redness, swelling, tenderness, itchiness of the left arm from the shoulder to pass the elbow area the next morning after the vaccine. There was no fever. Pt immediately got in to see her doctor and was given some steroids and antibiotics. She is now ok but still a little tender in the left arm.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Md's office reported 10/12/17 9:40 am about pt's adverse reactions (redness and swelling) to PNEUMOVAX 23 given at our pharmacy on 10/10/17 and instructed pt to contact the pharmacy to provide more details. Spoke to pt on 10/15/17 5:30pm who reported she had redness, swelling, tenderness, itchiness of the left arm from the shoulder to pass the elbow area the next morning after the vaccine. There was no fever. Pt immediately got in to see her doctor and was given some steroids and antibiotics. She is now ok but still a little tender in the left arm.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76-year-old male patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. The patient had no known drug reactions or allergies. On 04-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiry date were not reported). On an unknown date in October 2017, within 48 hours of PNEUMOVAX 23 vaccination, the patient developed cellulitis on the left arm. On 06-OCT-2017, the patient was seen in an unspecified physician's office. No lab diagnostics or studies were performed. It was unknown if treatment was given for the event. The outcome of the event was reported as recovering. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received 13-OCT-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was alleged that on 26-FEB-2015 the plaintiff was inoculated with ZOSTAVAX 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 her to contract a persistent strain of herpes zoster. On or about 03-OCT-2016 the plaintiff was treated by a physician at a medical center 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 or proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received 13-OCT-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. On or about 11-NOV-2015 the plaintiff was inoculated with ZOSTAVAX 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 her to contract a persistent strain of herpes zoster. On or about 03-JAN-2017 the plaintiff was treated by a nurse practitioner at an internal medicine facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles. The plaintiff had been prescribed acyclovir for management of her painful symptoms. As a direct or proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 13-OCT-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 29-SEP-2012 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. On or about 23-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin and famciclovir for management of her 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 a 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 13-OCT-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 21-MAY-2012 at 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. On or about 03-NOV-2014, the patient was treated at a health system for the onset of a severe vesicular rash accompanied by 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 a 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: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 13-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 11-NOV-2010 by a physician, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-FEB-2016, patient was treated by physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Patient had been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Anxiety, Depression, Malaise, Post-traumatic stress disorder, Sleep apnoea syndrome
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a currently 67-year-old male patient of an unspecified ethnicity received PREVNAR 13 at the age of 63 years, via an unspecified route of administration in Jun2014 at single dose for immunization. Medical history included type 2 diabetes mellitus. The patient's concomitant medications were not reported. It was reported that PTSD was diagnosed after this whole ordeal [Pneumococcal Pneumonia in JUN2014], and after this sickness, patient started to not want to do anything, kept people at a distance and ended up getting on medication for anxiety and depression. Patient also talk with a doctor one a month or so to keep him focused and positive. He was a type 2 diabetic now as well and have sleep apnea. During this whole process he lost 26 pounds. Consumer described having pneumococcal 13-val conj vac (dipht crm197 protein) shot in Jun2014 and again in Oct2016. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Weight decreased
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a currently 67-year-old male patient of an unspecified ethnicity received PREVNAR 13 at the age of 63 years, via an unspecified route of administration in Jun2014 at single dose for immunization. Medical history included type 2 diabetes mellitus. The patient's concomitant medications were not reported. It was reported that PTSD was diagnosed after this whole ordeal [Pneumococcal Pneumonia in JUN2014], and after this sickness, patient started to not want to do anything, kept people at a distance and ended up getting on medication for anxiety and depression. Patient also talk with a doctor one a month or so to keep him focused and positive. He was a type 2 diabetic now as well and have sleep apnea. During this whole process he lost 26 pounds. Consumer described having pneumococcal 13-val conj vac (dipht crm197 protein) shot in Jun2014 and again in Oct2016. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 66-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included hypertension diagnosed 25 years ago. The patient's concomitant medications were not reported. On an unspecified date the patient reported that she got pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and it hurt. The outcome of the event was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Vertigo
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program Patient Testimonial Recruitment. A non-contactable consumer reported that a male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 02Oct2017 at a single dose for pneumonia. The patient's medical history and concomitant medications were not reported. On Oct2017, couple days after vaccination, the patient experienced dizzy and vertigo. The outcome of the events was unknown. The patient wasn't sure if it was a side effect from the medicine. No follow up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pruritus generalised
Clinical narrative: HR called me on 10/4/17 @ 9:16 informing me that patient might be having a reaction to the employee flu vaccine given yesterday. I went to triage patient. She said after the injection in her left arm, her arm felt the typical soreness normal to her. By lunch time she started to feel a light itching in her left arm; and as the day wore on, the itching slowly spread through her whole body. This morning, the itching is intense, especially in the armpits, groin and bottom of the feet. She has not taken an antihistamine at this time. I encouraged her that she should and that I would let HR know the results of our meeting. I called HR and notified them. @ 2:45 PM I talked again to patient. She said she was actually feeling worse, even after taking a BENADRYL 25 mg at about 10 AM. I told her she should be seen by a medical provider and to contact HR. Clinic sent her to an outside medical facility. They gave her prednisone told patient to take 100 mg of BENADRYL which she took 75 mg. On 10/5 she started to feel better with intermittent itching and on the 6th was back to her normal self.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swelling, warmth of upper arm and forearm.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Received flu vaccine in left arm and non-PREVNAR 13 pneumonia vaccine in right arm. Not long after, on that day, experienced rather severe right upper arm pain. The pain subsided somewhat the next day, but has remained since then. No problem in left arm.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Throat tightness, Urticaria
Clinical narrative: Patient went home, before bed he started to feel chest tightness and throat tightness. After that resolved he woke up with worsening hives on flanks that spread over the next 3 days down legs and up trunk.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that the night after the injections he experienced a massive reaction in his right arm involving redness, swelling, and pain. Patient wanted to have one shot in one arm and the other shot in the other arm. The pharmacist who gave the shots said that there would be no problem with both shots in the same arm. Patient sought treatment at the emergency department and got a steroid shot to calm the reaction.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder, Syringe issue
Clinical narrative: During administration of flu vaccine in my Right shoulder, the plunger stopped before dose fully injected. There was a jolt as the person giving dose pushed harder to give the complete dose and pushed the plunger all the way. She explained what happened and said "Sorry". Within a couple hours, my arm was really aching. I took ibuprofen at home before bed. The next day it felt a little better, but a week out I started developing more pain with range of motion. The last few nights I take ibuprofen before bed and get woken up every time I move. I have to change all my movements to compensate for my shoulder pain with daily activities.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Immediate soreness in right arm and continued soreness especially when lifting arm above head. Icing and heat have been used as well as Ibuprofen with not much relief. The shot was given relatively high in the deltoid muscle.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting that occurred after vaccine administration.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Severe chills 9:00pm-10:30pm, profuse sweating, sore upper arm (injection site) day of injection. Bad headache 10/12/2017 most of the day (day after injection).
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Employee reports IM injection given too high up and severe pain since injection, worsening over the next couple hours and persisting 20 days later still.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Hyperhidrosis, Hypotonia, Pyrexia, Respiration abnormal
Clinical narrative: Patient is a 12 m.o. male who presents to the Emergency Department on 10/10/2017 @ 10:42 pm for evaluation of a spell. Child was sleeping in his bed. Mother noticed the child having some unusual breathing on the monitor. When she went in the room, child appeared limp and unresponsive. He was warm and diaphoretic. She states he was normal throughout the day. Eating and drinking well. No fever. Parents called EMS and child was noted to have a fever. No prior history of febrile seizures. No family history of febrile seizures. Mother is not concerned about any on accidental trauma. Child is up-to-date with vaccinations. No history of kidney or urinary disease. He is hitting his milestones appropriately.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Skin warm, Unresponsive to stimuli
Clinical narrative: Patient is a 12 m.o. male who presents to the Emergency Department on 10/10/2017 @ 10:42 pm for evaluation of a spell. Child was sleeping in his bed. Mother noticed the child having some unusual breathing on the monitor. When she went in the room, child appeared limp and unresponsive. He was warm and diaphoretic. She states he was normal throughout the day. Eating and drinking well. No fever. Parents called EMS and child was noted to have a fever. No prior history of febrile seizures. No family history of febrile seizures. Mother is not concerned about any on accidental trauma. Child is up-to-date with vaccinations. No history of kidney or urinary disease. He is hitting his milestones appropriately.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site rash
Clinical narrative: Patient reports rash underneath the injection site. Localized reddness the size of palm of hand. No itching, pain, pustules, or soreness. Rash started 24 hours after vaccine administration. She describes reaction as mild and has no prior reactions to flu vaccine in previous years. Followed up with patient on 10/16/17 and the rash has completely gone away.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: LEG WITH REDNESS AND SWELLING ALL THE WAY DOWN TO ANKLE. *CHILD WITH SIMILAR REACTION LAST YEAR AFTER FLU SHOT ALSO. ** SENDING A REFERRAL FOR CHILD TO SEE ALLERGIST.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Body aches, headache, vomiting, diarrhea, low grade fever developed in 1st 24 hours and lasted 2 days.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: From the patient: Friday evening I came down with dizziness, chills and a severe fever. My husband and I monitored it; it seemed to come in waves but was always at a steady 102 degrees. I was incredibly weak and had small waves of nausea ? only got sick once though, and was not really hungry most of the time. I was consistently cold but was sweating buckets. The site of the vaccine was slightly swollen, hot, and feverish to the touch. It felt like a stabbing pain/ache all weekend; I could not put any weight on it or it would be a pulsating pain. Currently it is a tinge sore if I move my shoulder a certain direction, but otherwise fine. There is a bruise where the lower injection was. My fever broke early Sunday morning and since then I have been utterly exhausted (though improving) and my left arm is still a bit weak, slowly recovering strength. I took the day off work Monday to sleep/rest some more.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Feeling cold, Injection site bruising, Muscular weakness, Nausea, Pain
Clinical narrative: From the patient: Friday evening I came down with dizziness, chills and a severe fever. My husband and I monitored it; it seemed to come in waves but was always at a steady 102 degrees. I was incredibly weak and had small waves of nausea ? only got sick once though, and was not really hungry most of the time. I was consistently cold but was sweating buckets. The site of the vaccine was slightly swollen, hot, and feverish to the touch. It felt like a stabbing pain/ache all weekend; I could not put any weight on it or it would be a pulsating pain. Currently it is a tinge sore if I move my shoulder a certain direction, but otherwise fine. There is a bruise where the lower injection was. My fever broke early Sunday morning and since then I have been utterly exhausted (though improving) and my left arm is still a bit weak, slowly recovering strength. I took the day off work Monday to sleep/rest some more.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth, Weight bearing difficulty
Clinical narrative: From the patient: Friday evening I came down with dizziness, chills and a severe fever. My husband and I monitored it; it seemed to come in waves but was always at a steady 102 degrees. I was incredibly weak and had small waves of nausea ? only got sick once though, and was not really hungry most of the time. I was consistently cold but was sweating buckets. The site of the vaccine was slightly swollen, hot, and feverish to the touch. It felt like a stabbing pain/ache all weekend; I could not put any weight on it or it would be a pulsating pain. Currently it is a tinge sore if I move my shoulder a certain direction, but otherwise fine. There is a bruise where the lower injection was. My fever broke early Sunday morning and since then I have been utterly exhausted (though improving) and my left arm is still a bit weak, slowly recovering strength. I took the day off work Monday to sleep/rest some more.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea and dizziness that lasted one hour after administration. Had student rest, drink water, and had parent pick up child from school.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site nodule, Injection site pain
Clinical narrative: Bleeding at injection site. Hard knot. Bruising and painful.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillane Barre Syndrome.
Age: 1.75
Sex: M
Vaccine: MMRV
Symptoms: Biopsy skin abnormal, Gianotti-Crosti syndrome, Rash erythematous, Rash pruritic, Scab
Clinical narrative: Initially was a rash on right upper inner thigh, topical steroid prescribed. 2 weeks later was spread to legs and arms, saw dermatologist different steroid applied, rash became more red and itchy. Returned to PCP and was sent out for biopsy. Diagnosed as Gianotti-Crosti disease. No acute illness before vaccination, one possible cold after vaccine was administered, but after rash had started. 4 weeks after rash started was suggested to try a homeopathic remedy. Tried sulphur 30c with no change, recommended to switch to Rhus tox 6c. Started on Friday 10/13 by saturday 10/14 rash had begun to clear, crusting began, no further spread .
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: CLIENT EXPERIENCED SORENESS AROUND INJECTION SITE DEVELOPING SEVERAL HOURS AFTER THE VACCINATION. THE SORENESS CONTINUED TO ESCALATE. REDNESS AND WARMTH  DEVELOPED AROUND THE INJECTION SITE  AND INCREASED IN  SIZE AND INTENSITY. THE CLIENT CALLED ON  MONDAY, SEPT. 25 TO ASK IF THIS WAS UNUSUAL. PT STATED THE WARM  REDNESS  WAS SLOWLY INCREASING IN SIZE AND THE DISCOMFORT WAS NOT IMPROVING. I WENT TO VISIT WITH HER IMMEDIATELY AT HER PLACE OF EMPLOYMENT. THE AFFECTED ARM IS NOTICIBLY  RED AND SWOLLEN. THE REDDENED AREA IS VERY WARM TO TOUCH. THE INJECTION SITE IS PURPLY IN COLOR. THE REDNESS IS A SOLID COLOR AND IS BLANCHABLE. THE RED AREA EXTENDS FROM THE TOP OF HER SHOULDER TO JUST ABOVE THE ELBOW JOINT AND HAS A DEFINITED LINE OF DEMARCATION.. THE CLIENT REPORTS NO SYSTEMIC SYMPTOMS. SHE SAID SHE WOULD TAKE AN OTC ANALGESIC AND WAIT A COUPLE OF DAYS MORE TO SEE WHAT HAPPENS. I CALLED HER ON 9/27/2017 AND PT STATED THE SYMPTOMS WERE SLOWLY RESOLVING. SHE DID NOT SEEK MEDICAL ATTENTION.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: CLIENT EXPERIENCED SORENESS AROUND INJECTION SITE DEVELOPING SEVERAL HOURS AFTER THE VACCINATION. THE SORENESS CONTINUED TO ESCALATE. REDNESS AND WARMTH  DEVELOPED AROUND THE INJECTION SITE  AND INCREASED IN  SIZE AND INTENSITY. THE CLIENT CALLED ON  MONDAY, SEPT. 25 TO ASK IF THIS WAS UNUSUAL. PT STATED THE WARM  REDNESS  WAS SLOWLY INCREASING IN SIZE AND THE DISCOMFORT WAS NOT IMPROVING. I WENT TO VISIT WITH HER IMMEDIATELY AT HER PLACE OF EMPLOYMENT. THE AFFECTED ARM IS NOTICIBLY  RED AND SWOLLEN. THE REDDENED AREA IS VERY WARM TO TOUCH. THE INJECTION SITE IS PURPLY IN COLOR. THE REDNESS IS A SOLID COLOR AND IS BLANCHABLE. THE RED AREA EXTENDS FROM THE TOP OF HER SHOULDER TO JUST ABOVE THE ELBOW JOINT AND HAS A DEFINITED LINE OF DEMARCATION.. THE CLIENT REPORTS NO SYSTEMIC SYMPTOMS. SHE SAID SHE WOULD TAKE AN OTC ANALGESIC AND WAIT A COUPLE OF DAYS MORE TO SEE WHAT HAPPENS. I CALLED HER ON 9/27/2017 AND PT STATED THE SYMPTOMS WERE SLOWLY RESOLVING. SHE DID NOT SEEK MEDICAL ATTENTION.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: PATIENT REPORTS THAT THE NEXT DAY AFTER RECEIVING THE INJECTION SHE NOTICED THAT AREA AT INJECTION SITE WAS WARM TO TOUCH. AREA SURROUNDING INJECTION SITE ERYTHEMATOUS AND APPROXIMATELY 3CM IN DIAMETER. AREA IS TENDER TO TOUCH AND PRURITIC. PATIENT HAS NOT TAKEN ANY MEDICATION FOR SYMPTOMS. NO PREVIOUS HX OF ADVERSE RXN TO INFLUENZA VACCINE.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Pt had area 6cm in diameter swollen on left arm. Treated with Keflex BID x 7 days.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had an allergic type reaction two days after receiving her Flu vaccine. She received the vaccine the morning of 10/14/2017 and was admitted to the Emergency Room the morning of 10/16/2017. She presented with itching at the injection site, severe redness and swelling, and it was hot to the touch. Patient did not report any symptoms the day of receiving the vaccine.