chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Vaccinated with MMR for neg. Rubeola titer (7/12/16). Reported hives/itching 30 minutes after vaccine up to 4 days. Self-medicated with BENADRYL and ZANTAC. Sought medical attention on 9/24/16 in local ER due to rash and fever. Diagnosed by ER MD and Health Dept with adverse reaction to measles vaccine. Subsequent Rubeola IgG neg. on 9/30/16, 10/4/16. IgM negative 10/4/16. Rash subsided by 10/4/16.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Vaccinated with MMR for neg. Rubeola titer (7/12/16). Reported hives/itching 30 minutes after vaccine up to 4 days. Self-medicated with BENADRYL and ZANTAC. Sought medical attention on 9/24/16 in local ER due to rash and fever. Diagnosed by ER MD and Health Dept with adverse reaction to measles vaccine. Subsequent Rubeola IgG neg. on 9/30/16, 10/4/16. IgM negative 10/4/16. Rash subsided by 10/4/16.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Right away large lump at site of injection. The lump has decreased in size. Patient said certain movements cause pain in his whole arm and he feels like he is losing strength. Now has small red spot with white central raised bump. Area under red spot is indurated, no fluctuance.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: Right away large lump at site of injection. The lump has decreased in size. Patient said certain movements cause pain in his whole arm and he feels like he is losing strength. Now has small red spot with white central raised bump. Area under red spot is indurated, no fluctuance.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Patient still has soreness and stiffness after 2 mos. post administration. General arm soreness has subsided but it's still painful to the touch.
Age: 19.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dizziness, Loss of consciousness, Muscle twitching, Nausea, Posture abnormal
Clinical narrative: Patient received Hep A vaccine in left arm. Chair was turned around to administer Influenza in Right Arm. Within 30 seconds of Influenza vaccination patient slumped in chair and had a temporary loss of consciousness. There appeared to be some arm twitching which may indicate some seizure activity. Her mother was outside of room in waiting area and came in and patient was moved to bench area to lie down. When consciousness was regained seconds later, patient reported feeling lightheaded and "queasy" but otherwise felt ok. Patient remained lying down with her mother and RPh for approx. 20mins in room, and then was walked to her car with her mother and a staff member. No additional action was taken. Mother was advised by RPH to notify healthcare provider of reaction, and to ensure that any future vaccinations, if recommended by provider, are administered in a more controlled healthcare setting.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Presyncope, Pyrexia
Clinical narrative: PATIENT EXPERIENCED WHAT APPEARED TO BE VASOVAGAL REACTION. SHE WAS FELT DIZZY WITH FEVER.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Activities of daily living impaired, Headache, Malaise
Clinical narrative: Patient began to have headaches and abdominal cramping.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash distal to injection site on right lateral deltoid, spread about 5cm diameter, was warm to touch and itchy. Rash remained for two days, decreasing in intensity of itching and heat. Oral BENADRYL was taken over-the-counter, topical anti-itch cream was applied. Symptoms disappeared four days after onset of rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Swelling
Clinical narrative: Large red, hot,swollen, itchy rash which lasted approx 10 days.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Patient noticed when she woke up the next day that the arm was sore and red.  The redness spread into two different splotches over the course of the week and remained painful to the touch.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient had requested Varicella vaccine but received MMR instead. No adverse symptoms being report.
Age: 30.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling near injection site and some redness.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient noticed left bicep turned red and tender, also had fever 12/28/16 and 12/29/16, pt took acetaminophen for 2 days.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left bicep turned very red and tender, about 3 to 4 inches from injection site. Put benadryl cream on area and taking acetaminophen 500mg.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthropathy, Autonomic nervous system imbalance, Complex regional pain syndrome, Dystonia, Fatigue
Clinical narrative: Complex Regional Pain Syndrome, Joint Hypermobility Syndrome, Orthostatic Hypotension, Dystonia, Dysautonomia, Tension Headaches, Migraines, Myofascial Pain Syndrome, Fibromyalgia, SI Joint Dysfunction, fatigue, Vasovagal Syncope.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fibromyalgia, Hypermobility syndrome, Migraine, Myofascial pain syndrome, Orthostatic hypotension
Clinical narrative: Complex Regional Pain Syndrome, Joint Hypermobility Syndrome, Orthostatic Hypotension, Dystonia, Dysautonomia, Tension Headaches, Migraines, Myofascial Pain Syndrome, Fibromyalgia, SI Joint Dysfunction, fatigue, Vasovagal Syncope.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope, Tension headache
Clinical narrative: Complex Regional Pain Syndrome, Joint Hypermobility Syndrome, Orthostatic Hypotension, Dystonia, Dysautonomia, Tension Headaches, Migraines, Myofascial Pain Syndrome, Fibromyalgia, SI Joint Dysfunction, fatigue, Vasovagal Syncope.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Muscle twitching, Pyrexia, Seizure, Strabismus, Unresponsive to stimuli
Clinical narrative: Seizure, high fever, unresponsiveness, twitching, eye squinting.
Age: 1.17
Sex: F
Vaccine: PNC13
Symptoms: Crying, Pain, Pyrexia, Somnolence, Tenderness
Clinical narrative: Child became very achy/sore over entire body. Every touch to the child and every movement to the child made her cry for several hours until she went to bed for the night. Fever and sleepiness was also present.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Flu vaccine given to patient to early. Patient only 4mos of age.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Seen in ER 12/24/16 for S/P febrile seizure after getting 1 y/o vaccines which given 12/21/16. Pt developed fever the following day after getting vaccines and had febrile seizure on 12/23/16. No history of febrile seizure prior to this episode.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool 1 day after 2nd ROTATEQ vaccine given.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cough, Pain, Pyrexia, Upper respiratory tract infection
Clinical narrative: Local soreness; also pt. had 3d HX/O URI SX prior to receiving vaccine. Pt. has Asthma. The night he got vaccine he coughed all night and ran fever. Examined the next day and TX'd with URI. RX - Albuterol.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Body temperature decreased, Chest X-ray normal, Cough, Fatigue, Productive cough
Clinical narrative: On 10-14-16 received my flu shot for this year. At our local health department. The nurse ask me what my allergies were. I told her penicillin and alcohol. I told her it was in my records there that she could look it up. She said ok. Gave the shot in the left arm. After the injection, I told the nurse that it really hurt and burned. And it still hurts some at the site today moderately. She may have gone into the bone, because I am so thin. Later that day started with sneezing, headache, cough. The next day fever and chills, runny nose and fatigue. Continuing the next day, more of the same but oxygen levels were up and down. I was coughing up yellow and brown phlegm all day. My symptoms were getting worse, called my friend to take me to the ER. They took me right in. I told them I had the flu shot a couple of days earlier at the Health Department. They did some tests, blood work and chest x-rays. Was put on IV's. There was three bags on the pole, don't remember a lot but the floor doctor came in and said that I was going to be admitted. In all my times of going to the ER, this was the fasts I ever was up on the floor. (two hours.) In the hospital five days. Coughing very hard, coughing up phlegm bright yellow and brown, sore throat, fevers and chills and muscle aches. Was coughing so hard that my skin turn purple from my right shoulder down my right side to hips, across back and around to private area. I had swelling from my waist to below my privates. Hard time sleeping, day or night. Sent me home on two weeks bed rest, only get up with help to go to the bathroom. Then could get up for short times. Tired all the time, not sleeping good. Still running low and high grade fevers. Still blotted in the stomach area. Dizzy and light headed, need to use a walker. Oxygen levels still up and down. Am on oxygen now 24-7, on level 2. Was not before, but am told I will be on oxygen for the rest of my life. Was active before this shot and hospital stay, and now can not do hardly anything at all. I am now on physical therapy to regain the strength and endurance that I lost because of the hospital stay because of the shot. Why did she not look up my records to make sure that I could have the injection because of my allergies?
Age: 69.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pyrexia, Rhinorrhoea, Sputum discoloured
Clinical narrative: On 10-14-16 received my flu shot for this year. At our local health department. The nurse ask me what my allergies were. I told her penicillin and alcohol. I told her it was in my records there that she could look it up. She said ok. Gave the shot in the left arm. After the injection, I told the nurse that it really hurt and burned. And it still hurts some at the site today moderately. She may have gone into the bone, because I am so thin. Later that day started with sneezing, headache, cough. The next day fever and chills, runny nose and fatigue. Continuing the next day, more of the same but oxygen levels were up and down. I was coughing up yellow and brown phlegm all day. My symptoms were getting worse, called my friend to take me to the ER. They took me right in. I told them I had the flu shot a couple of days earlier at the Health Department. They did some tests, blood work and chest x-rays. Was put on IV's. There was three bags on the pole, don't remember a lot but the floor doctor came in and said that I was going to be admitted. In all my times of going to the ER, this was the fasts I ever was up on the floor. (two hours.) In the hospital five days. Coughing very hard, coughing up phlegm bright yellow and brown, sore throat, fevers and chills and muscle aches. Was coughing so hard that my skin turn purple from my right shoulder down my right side to hips, across back and around to private area. I had swelling from my waist to below my privates. Hard time sleeping, day or night. Sent me home on two weeks bed rest, only get up with help to go to the bathroom. Then could get up for short times. Tired all the time, not sleeping good. Still running low and high grade fevers. Still blotted in the stomach area. Dizzy and light headed, need to use a walker. Oxygen levels still up and down. Am on oxygen now 24-7, on level 2. Was not before, but am told I will be on oxygen for the rest of my life. Was active before this shot and hospital stay, and now can not do hardly anything at all. I am now on physical therapy to regain the strength and endurance that I lost because of the hospital stay because of the shot. Why did she not look up my records to make sure that I could have the injection because of my allergies?
Age: 69.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Activities of daily living impaired, Blood test, Chest X-ray, Chills, Cough
Clinical narrative: On 10-14-16 received my flu shot for this year. At our local health department. The nurse ask me what my allergies were. I told her penicillin and alcohol. I told her it was in my records there that she could look it up. She said ok. Gave the shot in the left arm. After the injection, I told the nurse that it really hurt and burned. And it still hurts some at the site today moderately. She may have gone into the bone, because I am so thin. Later that day started with sneezing, headache, cough. The next day fever and chills, runny nose and fatigue. Continuing the next day, more of the same but oxygen levels were up and down. I was coughing up yellow and brown phlegm all day. My symptoms were getting worse, called my friend to take me to the ER. They took me right in. I told them I had the flu shot a couple of days earlier at the Health Department. They did some tests, blood work and chest x-rays. Was put on IV's. There was three bags on the pole, don't remember a lot but the floor doctor came in and said that I was going to be admitted. In all my times of going to the ER, this was the fasts I ever was up on the floor. (two hours.) In the hospital five days. Coughing very hard, coughing up phlegm bright yellow and brown, sore throat, fevers and chills and muscle aches. Was coughing so hard that my skin turn purple from my right shoulder down my right side to hips, across back and around to private area. I had swelling from my waist to below my privates. Hard time sleeping, day or night. Sent me home on two weeks bed rest, only get up with help to go to the bathroom. Then could get up for short times. Tired all the time, not sleeping good. Still running low and high grade fevers. Still blotted in the stomach area. Dizzy and light headed, need to use a walker. Oxygen levels still up and down. Am on oxygen now 24-7, on level 2. Was not before, but am told I will be on oxygen for the rest of my life. Was active before this shot and hospital stay, and now can not do hardly anything at all. I am now on physical therapy to regain the strength and endurance that I lost because of the hospital stay because of the shot. Why did she not look up my records to make sure that I could have the injection because of my allergies?
Age: 69.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Insomnia
Clinical narrative: On 10-14-16 received my flu shot for this year. At our local health department. The nurse ask me what my allergies were. I told her penicillin and alcohol. I told her it was in my records there that she could look it up. She said ok. Gave the shot in the left arm. After the injection, I told the nurse that it really hurt and burned. And it still hurts some at the site today moderately. She may have gone into the bone, because I am so thin. Later that day started with sneezing, headache, cough. The next day fever and chills, runny nose and fatigue. Continuing the next day, more of the same but oxygen levels were up and down. I was coughing up yellow and brown phlegm all day. My symptoms were getting worse, called my friend to take me to the ER. They took me right in. I told them I had the flu shot a couple of days earlier at the Health Department. They did some tests, blood work and chest x-rays. Was put on IV's. There was three bags on the pole, don't remember a lot but the floor doctor came in and said that I was going to be admitted. In all my times of going to the ER, this was the fasts I ever was up on the floor. (two hours.) In the hospital five days. Coughing very hard, coughing up phlegm bright yellow and brown, sore throat, fevers and chills and muscle aches. Was coughing so hard that my skin turn purple from my right shoulder down my right side to hips, across back and around to private area. I had swelling from my waist to below my privates. Hard time sleeping, day or night. Sent me home on two weeks bed rest, only get up with help to go to the bathroom. Then could get up for short times. Tired all the time, not sleeping good. Still running low and high grade fevers. Still blotted in the stomach area. Dizzy and light headed, need to use a walker. Oxygen levels still up and down. Am on oxygen now 24-7, on level 2. Was not before, but am told I will be on oxygen for the rest of my life. Was active before this shot and hospital stay, and now can not do hardly anything at all. I am now on physical therapy to regain the strength and endurance that I lost because of the hospital stay because of the shot. Why did she not look up my records to make sure that I could have the injection because of my allergies?
Age: 69.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Laboratory test, Myalgia, Oropharyngeal pain, Oxygen saturation abnormal, Productive cough
Clinical narrative: On 10-14-16 received my flu shot for this year. At our local health department. The nurse ask me what my allergies were. I told her penicillin and alcohol. I told her it was in my records there that she could look it up. She said ok. Gave the shot in the left arm. After the injection, I told the nurse that it really hurt and burned. And it still hurts some at the site today moderately. She may have gone into the bone, because I am so thin. Later that day started with sneezing, headache, cough. The next day fever and chills, runny nose and fatigue. Continuing the next day, more of the same but oxygen levels were up and down. I was coughing up yellow and brown phlegm all day. My symptoms were getting worse, called my friend to take me to the ER. They took me right in. I told them I had the flu shot a couple of days earlier at the Health Department. They did some tests, blood work and chest x-rays. Was put on IV's. There was three bags on the pole, don't remember a lot but the floor doctor came in and said that I was going to be admitted. In all my times of going to the ER, this was the fasts I ever was up on the floor. (two hours.) In the hospital five days. Coughing very hard, coughing up phlegm bright yellow and brown, sore throat, fevers and chills and muscle aches. Was coughing so hard that my skin turn purple from my right shoulder down my right side to hips, across back and around to private area. I had swelling from my waist to below my privates. Hard time sleeping, day or night. Sent me home on two weeks bed rest, only get up with help to go to the bathroom. Then could get up for short times. Tired all the time, not sleeping good. Still running low and high grade fevers. Still blotted in the stomach area. Dizzy and light headed, need to use a walker. Oxygen levels still up and down. Am on oxygen now 24-7, on level 2. Was not before, but am told I will be on oxygen for the rest of my life. Was active before this shot and hospital stay, and now can not do hardly anything at all. I am now on physical therapy to regain the strength and endurance that I lost because of the hospital stay because of the shot. Why did she not look up my records to make sure that I could have the injection because of my allergies?
Age: 69.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pyrexia, Rhinorrhoea, Skin discolouration, Sneezing, Sputum discoloured
Clinical narrative: On 10-14-16 received my flu shot for this year. At our local health department. The nurse ask me what my allergies were. I told her penicillin and alcohol. I told her it was in my records there that she could look it up. She said ok. Gave the shot in the left arm. After the injection, I told the nurse that it really hurt and burned. And it still hurts some at the site today moderately. She may have gone into the bone, because I am so thin. Later that day started with sneezing, headache, cough. The next day fever and chills, runny nose and fatigue. Continuing the next day, more of the same but oxygen levels were up and down. I was coughing up yellow and brown phlegm all day. My symptoms were getting worse, called my friend to take me to the ER. They took me right in. I told them I had the flu shot a couple of days earlier at the Health Department. They did some tests, blood work and chest x-rays. Was put on IV's. There was three bags on the pole, don't remember a lot but the floor doctor came in and said that I was going to be admitted. In all my times of going to the ER, this was the fasts I ever was up on the floor. (two hours.) In the hospital five days. Coughing very hard, coughing up phlegm bright yellow and brown, sore throat, fevers and chills and muscle aches. Was coughing so hard that my skin turn purple from my right shoulder down my right side to hips, across back and around to private area. I had swelling from my waist to below my privates. Hard time sleeping, day or night. Sent me home on two weeks bed rest, only get up with help to go to the bathroom. Then could get up for short times. Tired all the time, not sleeping good. Still running low and high grade fevers. Still blotted in the stomach area. Dizzy and light headed, need to use a walker. Oxygen levels still up and down. Am on oxygen now 24-7, on level 2. Was not before, but am told I will be on oxygen for the rest of my life. Was active before this shot and hospital stay, and now can not do hardly anything at all. I am now on physical therapy to regain the strength and endurance that I lost because of the hospital stay because of the shot. Why did she not look up my records to make sure that I could have the injection because of my allergies?
Age: 69.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Swelling, Walking aid user
Clinical narrative: On 10-14-16 received my flu shot for this year. At our local health department. The nurse ask me what my allergies were. I told her penicillin and alcohol. I told her it was in my records there that she could look it up. She said ok. Gave the shot in the left arm. After the injection, I told the nurse that it really hurt and burned. And it still hurts some at the site today moderately. She may have gone into the bone, because I am so thin. Later that day started with sneezing, headache, cough. The next day fever and chills, runny nose and fatigue. Continuing the next day, more of the same but oxygen levels were up and down. I was coughing up yellow and brown phlegm all day. My symptoms were getting worse, called my friend to take me to the ER. They took me right in. I told them I had the flu shot a couple of days earlier at the Health Department. They did some tests, blood work and chest x-rays. Was put on IV's. There was three bags on the pole, don't remember a lot but the floor doctor came in and said that I was going to be admitted. In all my times of going to the ER, this was the fasts I ever was up on the floor. (two hours.) In the hospital five days. Coughing very hard, coughing up phlegm bright yellow and brown, sore throat, fevers and chills and muscle aches. Was coughing so hard that my skin turn purple from my right shoulder down my right side to hips, across back and around to private area. I had swelling from my waist to below my privates. Hard time sleeping, day or night. Sent me home on two weeks bed rest, only get up with help to go to the bathroom. Then could get up for short times. Tired all the time, not sleeping good. Still running low and high grade fevers. Still blotted in the stomach area. Dizzy and light headed, need to use a walker. Oxygen levels still up and down. Am on oxygen now 24-7, on level 2. Was not before, but am told I will be on oxygen for the rest of my life. Was active before this shot and hospital stay, and now can not do hardly anything at all. I am now on physical therapy to regain the strength and endurance that I lost because of the hospital stay because of the shot. Why did she not look up my records to make sure that I could have the injection because of my allergies?
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Herpes zoster disseminated, Polymerase chain reaction positive, Rash, Rash vesicular, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 64-year-old male patient with DM (diabetes mellitus) and hypersensitivity (also reported as unspecified reaction) to VASOTEC. The patient's medical history included pancreatic cyst, Whipple procedure, constipation, anal fissure and chickenpox in childhood. He had no medical history of Herpes Zoster or Herpes Zoster ophthalmicus. He had no recent VZV (Varicella Zoster Virus) exposure neither to chickenpox nor shingles. His concomitant medications included: FLOMAX, calcium, vitamin D, LASIX, BENEFIBER, pravastatin, and senna. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (0.65 ml in the left deltoid; lot# M035149; route of administration and expiration date were not provided) for the prevention of zoster. On 07-DEC-2016, the patient experienced diffuse body rash that was diagnosed as chickenpox rash. It was described as a hundreds of lesions distributed on the whole body including the face. On 18-DEC-2016, the patient was admitted to hospital due to the adverse events. He was started on acyclovir. On 18-DEC-2016, samples to laboratory examination were collected and the patient had Varicella-Zoster PCR (Polymerase Chain Reaction) performed, (result: positive) and on unknown date in December 2016, IgG antibody test (result: negative). The patient did not recover from the adverse event (the outcome also reported as recovered, date not provided). The physician stated that the patient was still hospitalized at the time of the report. The relatedness between the chickenpox and ZOSTAVAX was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Blood immunoglobulin G normal, Polymerase chain reaction positive, Rash generalised, Skin lesion, Varicella
Clinical narrative: This spontaneous report as received from a physician refers to a 64-year-old male patient with DM (diabetes mellitus) and hypersensitivity (also reported as unspecified reaction) to VASOTEC. The patient's medical history included pancreatic cyst, Whipple procedure, constipation, anal fissure and chickenpox in childhood. He had no medical history of Herpes Zoster or Herpes Zoster ophthalmicus. He had no recent VZV (Varicella Zoster Virus) exposure neither to chickenpox nor shingles. His concomitant medications included: FLOMAX, calcium, vitamin D, LASIX, BENEFIBER, pravastatin, and senna. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (0.65 ml in the left deltoid; lot# M035149; route of administration and expiration date were not provided) for the prevention of zoster. On 07-DEC-2016, the patient experienced diffuse body rash that was diagnosed as chickenpox rash. It was described as a hundreds of lesions distributed on the whole body including the face. On 18-DEC-2016, the patient was admitted to hospital due to the adverse events. He was started on acyclovir. On 18-DEC-2016, samples to laboratory examination were collected and the patient had Varicella-Zoster PCR (Polymerase Chain Reaction) performed, (result: positive) and on unknown date in December 2016, IgG antibody test (result: negative). The patient did not recover from the adverse event (the outcome also reported as recovered, date not provided). The physician stated that the patient was still hospitalized at the time of the report. The relatedness between the chickenpox and ZOSTAVAX was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, MMR, VARZOS, UNK, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a mother concerning her 2 year old daughter. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. The reporter stated that on 15-DEC-2016 (reported as yesterday), the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis by accident, along with other vaccines (did not disclose the names of the other vaccine) in her leg (did not disclose which leg) (Inappropriate schedule of vaccine administered). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, MMR, VARZOS, UNK, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a mother concerning her 2 year old daughter. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. The reporter stated that on 15-DEC-2016 (reported as yesterday), the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis by accident, along with other vaccines (did not disclose the names of the other vaccine) in her leg (did not disclose which leg) (Inappropriate schedule of vaccine administered). Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Eye pain, Ocular hyperaemia, Oropharyngeal pain, Pain of skin
Clinical narrative: Extreme sensitive scalp, pain in eye, very red eye, ear ache, slight sore throat; all on the right side of my head.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the unspecified patients were vaccinated with unspecified doses of GARDASIL 9 (dose, lot number and expiration date were unknown) following a temperature excursion for prophylaxis. No adverse effects were reported. Follow up information was received on 29-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA001061: US-009507513-1611USA001062: US-009507513-1611USA001063: US-009507513-1611USA001064: US-009507513-1611USA001065: US-009507513-1611USA001066: MERCK 1610USA011064:Mfr number.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (reported also as radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified numbers of patients were vaccinated with improperly stored dose of GARDASIL lot # K010215 and expiration date 05-MAY-2017 (dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. With a data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. This is a Corrected report. The HCP confirmed for the primary reporter was changed from Yes to NO, as this is a technician. Follow up information was received on 28-DEC-2016. As of 28-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA002274: US-009507513-1611USA002275: US-009507513-1611USA002276: US-009507513-1611USA002277: MERCK 1610USA012323:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates the patients received an improperly stored doses of GARDASIL 9 (dose, route and frequency unknown) (lot # M023169, expired date 13-JUN-2018) for prophylaxis. No adverse effects reported. The GARDASIL 9 was exposed to 54.32F for a time frame of 8 hours. There were no previous temperature excursion and no data logger involved. Follow-up information was received on 29-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.; Sender's Comments: , MERCK 1611USA000999:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as a radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified numbers of patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L026602 and expiration date 19-OCT-2017) and (lot # L036301 and expiration date 20-DEC-2017) (dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported.  Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. This information was from a digital data logger. No product quality complaint (PQC) was involved.   This is one of several reports received from the same source. Follow up information was received on 28-DEC-2016. As of 28-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Narrative was updated.; Sender's Comments: US-009507513-1611USA002274:US-009507513-1611USA002276: US-009507513-1611USA002277: US-009507513-1610USA012323:, MERCK 1611USA002275:Mfr number.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old female patient. The patient's concurrent conditions included hypertension, high cholesterol and diabetes. She had no drug reactions or allergies. No pertinent medical history was reported. Concomitant therapies included unspecified high blood pressure medicines, unspecified diabetes medicines and unspecified high cholesterol medicines. On 11-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route and anatomical location of administration were not reported). On an unspecified date in 2016, after receiving PNEUMOVAX 23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and she was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from the cellulitis (redness and swelling at the injection site). The relatedness between the event and therapy with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is one of several reports received from the same reporter. Follow up information has been received from the reporting registered nurse on 20-DEC-2016. The report referred to a female patient. On 11-OCT-2016 at 11:31, she was vaccinated with PNEUMOVAX 23, intramuscularly, in right deltoid. On 13-OCT-2016 at 11:30, she was diagnosed with cellulitis of the right arm (injection site cellulitis). She was treated with KEFLEX, 500 mg three times a day for 10 days. She was also advised she could take BENADRYL 25 mg. The patient recovered on 23-OCT-2016. Additional information is not expected as all scheduled correspondence has been received. This is a downgraded report. The event of cellulitis was changed to injection site cellulitis and therefore is not considered as medically significant event. Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007077: US-009507513-1611USA007096: US-009507513-1611USA007131: MERCK 1611USA007088:Mfr number.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning an 82 year old female patient. The patient's concurrent conditions included hypertension, thyroid issue, high cholesterol and diabetes. There were no drug reactions or allergies. No pertinent medical history was reported. Concomitant therapies included unspecified high blood pressure medicine, unspecified diabetes medicine, high cholesterol medicine and unspecified thyroid medicine. On 17-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route, anatomical location of administration and expiration date were not reported). Other suspect medications were not reported. On 19-OCT-2016, after receiving PNEUMOVAX 23, the patient experienced redness and swelling around the injection site, the swelling was from "her armpit all the way down to the elbow" and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and she was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On an unknown date in 2016, the patient recovered from the cellulitis. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is one of several reports received from the same reporter. Follow up information has been received from the nurse on 20-DEC-2016. It was reported that on 17-OCT-2016 at 10:58 AM, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly at right deltoid for prophylaxis. On 19-OCT-2016 at 16:14, the patient had arm hurting from armpit to elbow, it was red and swollen. It was warm to touch. The patient received cephalexin 500 mg tid (three times a day) for 7 days and MEDROL dose pack. The patient was recovered from the event on 27-OCT-2016. Additional information is not expected as all the follow up information has been received. Reporter, Patient, Product, Event and Narrative have been updated.; Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007077: US-009507513-1611USA007088: US-009507513-1611USA007131: MERCK 1611USA007096:Mfr number.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown date, the patient was inadvertently administered a pediatric dose 0.5 ml of VAQTA (route and lot # unknown) instead of an adult dose of l ml of VAQTA for prophylaxis. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient (nurse practitioner) who is currently 52 years old. The patient's pertinent medical history included asthma. Drug Reactions/Allergies were unknown. On an unknown date in October 2016, the patient was vaccinated with ZOSTAVAX lot # L027321, expiry date 21-OCT-2016, 0.65 ml, subcutaneous route for the prevention of shingles. Concomitant therapies included unspecified flu vaccine (unspecified) vaccinated a week prior to ZOSTAVAX. Approximately in October 2016 (reported as "on the first day after ZOSTAVAX vaccination), the patient developed a "swollen elongated wheal type rash and it was raised." Approximately in 2016 (reported as "on the second day of vaccination"), the patient's arm "had a softball size welt that was warm to the touch" and on the third day of post vaccination, the rash was improving, became lighter. However, the patient felt "super tired but couldn't sleep" and experienced severe muscle aches and severe rigors". Approximately in 2016 (reported as "on the 4th day of vaccination"), the patient developed a bad fever of 104 degrees, headache. The patient still had muscle aches, but the aches were more mild. The rash was still present although the rash continued to lessen and become lighter. The patient was treated with ADVIL and TYLENOL for the adverse events. On the fifth day of vaccination, the patient started to recover from her adverse reactions. At the time of reporting, the patient had full recovery from the adverse events (approximately in 2016). Causality assessment was not provided. Product quality complaint (PQC) was not involved. No further information was available. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm, Urticaria
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient (nurse practitioner) who is currently 52 years old. The patient's pertinent medical history included asthma. Drug Reactions/Allergies were unknown. On an unknown date in October 2016, the patient was vaccinated with ZOSTAVAX lot # L027321, expiry date 21-OCT-2016, 0.65 ml, subcutaneous route for the prevention of shingles. Concomitant therapies included unspecified flu vaccine (unspecified) vaccinated a week prior to ZOSTAVAX. Approximately in October 2016 (reported as "on the first day after ZOSTAVAX vaccination), the patient developed a "swollen elongated wheal type rash and it was raised." Approximately in 2016 (reported as "on the second day of vaccination"), the patient's arm "had a softball size welt that was warm to the touch" and on the third day of post vaccination, the rash was improving, became lighter. However, the patient felt "super tired but couldn't sleep" and experienced severe muscle aches and severe rigors". Approximately in 2016 (reported as "on the 4th day of vaccination"), the patient developed a bad fever of 104 degrees, headache. The patient still had muscle aches, but the aches were more mild. The rash was still present although the rash continued to lessen and become lighter. The patient was treated with ADVIL and TYLENOL for the adverse events. On the fifth day of vaccination, the patient started to recover from her adverse reactions. At the time of reporting, the patient had full recovery from the adverse events (approximately in 2016). Causality assessment was not provided. Product quality complaint (PQC) was not involved. No further information was available. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown demographics. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 12-DEC-2016, "three months off schedule", the patient was vaccinated with a third dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, medical histories, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ taken orally, lot # M025565, expiration date 06-NOV-2017 (dose was not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Administered doses of vaccines were exposed to the temperature of 46.8 degrees Fahrenheit for 2 hours (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011634.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, medical histories, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M018810, expiration date 28-MAY-2018 (dose was not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Administered doses of vaccines were exposed to the temperature of 46.8 degrees Fahrenheit for 2 hours (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA007060.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown gender and age. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were administered improperly stored doses of VARIVAX injection, lot# reported, expiration date 13-JUL-2018 (dose and route of administration were not reported) for prophylaxis. Digital data logger was involved. It was reported that the vaccines were exposed to temperature of 7.5 Fahrenheit degrees for 2 hours 6 minutes before administration to the patients. No prior temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, once, subcutaneously (expiry date: October 2016, lot # unknown) for prophylaxis. No adverse effects were noted. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 23-DEC-2016, the patient was inadvertently vaccinated in addition to a scheduled dose of VARIVAX with a dose of PROQUAD, (lot # M007965 with an expiration date in 15-AUG-2017), for prophylaxis. No adverse event was reported and no product quality complaint was involved. Additional information has been requested.