chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Capillary nail refill test, Fatigue, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Injection site to left deltoid noted to have moderate edema, erythema to a 3in by 5in area. Site hot and extremely tender to touch. Weakness noted to left arm. Unable to elevate arm passed a ninety degree angle. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O severe weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing, nausea, vomiting, or diarrhea.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Muscular weakness
Clinical narrative: Injection site to left deltoid noted to have moderate edema, erythema to a 3in by 5in area. Site hot and extremely tender to touch. Weakness noted to left arm. Unable to elevate arm passed a ninety degree angle. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O severe weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing, nausea, vomiting, or diarrhea.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Bed rest, Exposure during pregnancy, Haemorrhage in pregnancy, Premature delivery, Premature labour
Clinical narrative: 34 weeks pregnant at time of vaccination. Start of preterm labor the evening after receiving the flu vaccination on 09/27/2017. I had just had my OBGYN appointment that morning and everything checked out fine. Received the flu vaccine at the end of the appointment. Went to hospital on 09/27/2017 for bleeding at 34 weeks gestation. Admitted for preterm labor. Preterm labor continued on and off for the next few days. Was in the hospital until 10/02/2017 and was sent home on bedrest. Preterm rupture of membranes occurred at home on 10/03/2017. Baby was born at 35 weeks gestation on weighing 5lbs 6oz. Baby kept in hospital for 12 more days. Due date was 11/05/2017.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Preterm premature rupture of membranes
Clinical narrative: 34 weeks pregnant at time of vaccination. Start of preterm labor the evening after receiving the flu vaccination on 09/27/2017. I had just had my OBGYN appointment that morning and everything checked out fine. Received the flu vaccine at the end of the appointment. Went to hospital on 09/27/2017 for bleeding at 34 weeks gestation. Admitted for preterm labor. Preterm labor continued on and off for the next few days. Was in the hospital until 10/02/2017 and was sent home on bedrest. Preterm rupture of membranes occurred at home on 10/03/2017. Baby was born at 35 weeks gestation on weighing 5lbs 6oz. Baby kept in hospital for 12 more days. Due date was 11/05/2017.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: POSSIBLE CELLULITIS, SWELLIG, REDNESS, HEAT.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: Local inflammation of left upper arm.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Red hot, swollen knot on vaccination arm. Started going away after 24 hours.
Age: 1.58
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Vaccination error
Clinical narrative: The patient came into office with mother, was thought and misinterpreted patient needing Hepatitis A and Influenza. Mother notified of error, CDC called, PCP notified.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5 x 6 cm area of erythema, slight heat on left deltoid. Not indurated, slightly tender.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Developed rash on the injection site with swelling and pain 4-6 hours after procedure. Self med with BENADRYL  and TYLENOL.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chills, Influenza virus test, Myalgia, Pain in extremity
Clinical narrative: Developed fever up to 101.7, generalized myalgias, chills, nausea for first 2 days, then developed rash at vaccine site, which has progressed to L arm cellulitis and persistent arm pain and swelling.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pregnancy test, Pyrexia, Urine analysis, Vaccination site rash
Clinical narrative: Developed fever up to 101.7, generalized myalgias, chills, nausea for first 2 days, then developed rash at vaccine site, which has progressed to L arm cellulitis and persistent arm pain and swelling.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting several times one hour after receiving vaccines.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Tremor, Visual impairment
Clinical narrative: 3/8/18 HA and visual anomalies at 6:00 p.m. I took acetaminophen 500 mg caps x 2. 3/9/18 0155 = severe chills and shaking x approx. 45 minutes. 10A=repeated acetaminophen dose for HA.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This spontaneous case, initially received on 24-Feb-2018, was reported by other non-health professional and concerns a female patient of unspecified age. The patient's relevant medical history and relevant concomitant medications were not reported. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195210, dose, route of administration, anatomical location, expiry date: not reported). On 24-Feb-2018, after 4 months 15 days of vaccination, the patient was diagnosed with "flu strain B" [explicitly coded as vaccination failure]. At the time of this report, the outcome of the event was not reported.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Pt called the next day when reaction started. Pain in deltoid region of left arm, redness and swelling. Blotches around site of injection. Pt instructed to take BENADRYL- and F/U if the reaction did not resolve. Pt applied ice/then heat helped better. Pt had PREVNAR 13 on 1/19/2017 with no reaction.
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Basedow's disease, Metal poisoning
Clinical narrative: This spontaneous case, was initially received on 21-Feb-2018, was reported by other non-health professional and concerns an adult male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with H1N1 influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, after vaccination, the patient had mercury poisoning and was diagnosed with Graves' disease. The outcome of the events: Grave's disease and mercury poisoning was not reported.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: The case was reported by a nurse via call center representative and described the occurrence of vomiting in a 23-year-old female patient who received RABAVERT. Concomitant products included RABAVERT, RABAVERT and RABAVERT. On an unknown date, the patient received the 4th dose of RABAVERT. On an unknown date, less than a day after receiving RABAVERT, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting and nausea were unknown. It was unknown if the reporter considered the vomiting and nausea to be related to RABAVERT. Additional details were provided as follows: It was unknown whether the patient received RABAVERT for pre or post exposure prophylaxis. The age at vaccination was not reported. On an unknown date, the patient received 1st and 2nd dose of RABAVERT. After RABAVERT, patient experienced nausea and vomiting within 24 hours of injection. This was 1 of 3 cases reported by same reporter for same patient.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Patient received flu shot 2-6-18. Called pharmacy 3-10-18 extreme pain for one month.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain
Clinical narrative: Patient received flu shot 2-6-18. Called pharmacy 3-10-18 extreme pain for one month.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV, VARCEL
Symptoms: Arthralgia, Oedema peripheral, Pyrexia, Rash morbilliform
Clinical narrative: Mobiliform rash, tactile fevers, bilateral knee edema/pain, bilateral feet edema.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: Extremely sore joints. Red swollen spots and lumps all over right upper arm not just on the injection site. Exhaustion.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Extremely sore joints. Red swollen spots and lumps all over right upper arm not just on the injection site. Exhaustion.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain
Clinical narrative: Patient said she had no muscle pain or soreness immediately following the vaccine, but severe pain at vaccine site began about 1 week following the vaccine, and has continued. When the pain began she had trouble lifting a gallon of milk. At this point she has full range of motion but says it feels like the needle is still going into her arm. No redness, swelling, muscle wasting, nodule, or any other symptoms reported.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haematochezia
Clinical narrative: Bloody stool.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site pain, Neck pain
Clinical narrative: Patient presented to the pharmacy the day following vaccination, she reported having soreness/redness at the injection site as well as pain in her neck, upper back, and wrist areas starting the evening of vaccination. When I examined the area on the day following vaccination the pain had subsided for her however there was still some redness around the injection site which looked like an injection site reaction. She was instructed to ice the area, take benadryl and to call/return if symptoms got worse or did not improve.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Pain after the shot has never gone away.
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Cognitive disorder, Feeling abnormal, Insomnia, Lethargy
Clinical narrative: Beginning within about 9 hours of vaccination both arms became sore. Soreness peaked between 12:00 am and 4 :00am on 3/9/2018 and prevented sleep during much of night. Following morning experienced most stated common symptoms with significant lethargy during the next day. In afternoon of next day 3/9 approximately 24 hrs after shot, awoke from nap and experienced inability to understand and mentally process information in communicating with my wife and experienced an overall dazed state. This seemed to last several hours and appeared improved with food intake. Had followed sitting in sun about 60 degrees for about 1 hr. in late morning /early afternoon. Arm soreness dissipated approx 15 hrs after shot and discontinued completely after about 18 hrs. At approx 10 pm on 3/9 or @ 31 hrs after shot began to felt better. Had no disturbing systems throughout night of 3/9-3/10. Awaking at @ 8a.m. on 3/10 only remaining symptoms seemed to be that of some lingering low energy level/lethargy. This was my first immunization in about 9 years and only 2nd in about 30 years. No prior similar history. Believe it may be possible the combination of the Shingles and Pneumonia vaccinations may have been overly strong and perhaps should be avoided?
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Beginning within about 9 hours of vaccination both arms became sore. Soreness peaked between 12:00 am and 4 :00am on 3/9/2018 and prevented sleep during much of night. Following morning experienced most stated common symptoms with significant lethargy during the next day. In afternoon of next day 3/9 approximately 24 hrs after shot, awoke from nap and experienced inability to understand and mentally process information in communicating with my wife and experienced an overall dazed state. This seemed to last several hours and appeared improved with food intake. Had followed sitting in sun about 60 degrees for about 1 hr. in late morning /early afternoon. Arm soreness dissipated approx 15 hrs after shot and discontinued completely after about 18 hrs. At approx 10 pm on 3/9 or @ 31 hrs after shot began to felt better. Had no disturbing systems throughout night of 3/9-3/10. Awaking at @ 8a.m. on 3/10 only remaining symptoms seemed to be that of some lingering low energy level/lethargy. This was my first immunization in about 9 years and only 2nd in about 30 years. No prior similar history. Believe it may be possible the combination of the Shingles and Pneumonia vaccinations may have been overly strong and perhaps should be avoided?
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: PATIENT EXPERIENCED REDNESS/SWELLING FROM INJECTION SITE DOWN PAST ELBOW, PAIN, CHILLS, FEVER, MUSCLE ACHES AND FATIGUE FOR A FEW DAYS AFTER INJECTION
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT EXPERIENCED REDNESS/SWELLING FROM INJECTION SITE DOWN PAST ELBOW, PAIN, CHILLS, FEVER, MUSCLE ACHES AND FATIGUE FOR A FEW DAYS AFTER INJECTION
Age: 78.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low grade fever of 101F and tiredness.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Periarthritis, Rotator cuff syndrome, X-ray
Clinical narrative: Frozen shoulder and rotator cuff injury. Doctor advised physical therapy. Went for physical therapy for about five weeks. Still doing exercises at home. Rate of Improvement is extremely slow. Therapist mentioned could take a year or more to improve.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Allergy test negative, Eczema
Clinical narrative: Broke out in eczema all over his body. Recurring eczema, especially on his face. At its worst, his face was raw and oozing and there were similar patches on his arm, leg and stomach.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Autism spectrum disorder, Developmental regression, Feeding disorder
Clinical narrative: Severe developmental regression which led to Autism, and a severe feeding disorder. Patient was healthy and thriving. She always met milestones. Suddenly after her 15 month vaccinations she lost everything she learned. My child was forever changed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Pain in extremity, Pyrexia
Clinical narrative: Fever starting about 8 hours after injection, lasting about 24 hours. Abdominal pain about 8 hours after injection lasting 24 hours. Soreness in injection arm still present after almost 48 hours.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Pain
Clinical narrative: In addition to soreness at injection site, flu-like symptoms (aches, chills, fatigue) began about 3 hours after injection and became worse over time. The day after the injection I felt as if I had very bad flu and stayed in bed much of the day. I felt much better after another night's sleep, just somewhat washed out and the injection site was still tender. I had the ZOSTAVAX injection about two years before.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Vomiting, nausea, tiredness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Headache, Tremor
Clinical narrative: 12 hours after admin I had onset of 5 hours of shaking chills in bed. I had trouble getting up to urinate, walking straight and selecting some TYLENOL with codeine and CELEBREX from the medicine cabinet as my hands shook so badly. Now in the AM I have a mild HA addressed with more TYLENOL 1000 mg. I am a physician. I will get my second vaccination in two months but will be sure to get it on a weekend. Fever but not chills were listed on my handout so I though it well to report this side effect for possible inclusion in the patient handout if this turns up more in the future. I informed the pharmacist to lookout for this when I called to get the lot number.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Sore shoulder/arm for 2 days. Couldn't lift arm. Too sore to sleep well on. Better 4 days after immunization.
Age: 51.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Left arm general soreness with gradual increase in swelling and redness. Unable to sleep on arm due to pain awakening me. The symptoms were worst between 03/07-03/09. It was very difficult to move my arm without pain. I am still experiencing this to a lesser extent. My arm is still swollen up about 1/2" to 1" in an area about 6"x 4" with a warm red area about 2"x4" at the lower end of the raised area. It is somewhat firm about 1&1/2" radius from the initial injection, which looks like a big mosquito bite or red zit. I also started experiencing a fever at around 2:00 pm on 03/07. This was the same day I started the live Typhoid series (as it is supposed to be taken on an empty stomach). This fever started low, and rose and fell between 100 and 101.7 on 03/08. I thought it was gone, but about 8 hours after my second oral dose of Typhoid, a low grade fever came back for the day on 03/09. That fever only lasted the one day, and never went over 100.5. I am now on my third live dose of Typhoid and am hoping for the best.
Age: 51.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Sleep disorder, Swelling
Clinical narrative: Left arm general soreness with gradual increase in swelling and redness. Unable to sleep on arm due to pain awakening me. The symptoms were worst between 03/07-03/09. It was very difficult to move my arm without pain. I am still experiencing this to a lesser extent. My arm is still swollen up about 1/2" to 1" in an area about 6"x 4" with a warm red area about 2"x4" at the lower end of the raised area. It is somewhat firm about 1&1/2" radius from the initial injection, which looks like a big mosquito bite or red zit. I also started experiencing a fever at around 2:00 pm on 03/07. This was the same day I started the live Typhoid series (as it is supposed to be taken on an empty stomach). This fever started low, and rose and fell between 100 and 101.7 on 03/08. I thought it was gone, but about 8 hours after my second oral dose of Typhoid, a low grade fever came back for the day on 03/09. That fever only lasted the one day, and never went over 100.5. I am now on my third live dose of Typhoid and am hoping for the best.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt experienced pain later that day and next morning. States arm was swollen, tight, painful from elbow through shoulder and up neck. Pain on movement. Relief with OTC APAP.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Capillary nail refill test, Fatigue, Headache, Injection site erythema
Clinical narrative: Injection site to right deltoid noted to have mild edema, erythema to a 2in by 3in area - marked with sharpie. Site hot and extremely tender to touch. Weakness noted to right arm. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing. Reports headache and has emesis twice.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Muscular weakness, Vomiting
Clinical narrative: Injection site to right deltoid noted to have mild edema, erythema to a 2in by 3in area - marked with sharpie. Site hot and extremely tender to touch. Weakness noted to right arm. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing. Reports headache and has emesis twice.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Capillary nail refill test, Fatigue, Headache, Injection site erythema
Clinical narrative: Injection site to left deltoid noted to have moderate edema, erythema to a 3in by 5in area - marked with sharpie. Site hot and extremely tender to touch. Weakness noted to left arm. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing, nausea, vomiting, or diarrhea. Reports headache and triple vision in the morning.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Muscular weakness, Visual impairment
Clinical narrative: Injection site to left deltoid noted to have moderate edema, erythema to a 3in by 5in area - marked with sharpie. Site hot and extremely tender to touch. Weakness noted to left arm. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing, nausea, vomiting, or diarrhea. Reports headache and triple vision in the morning.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Depression, Fatigue, Injection site pain, Nausea
Clinical narrative: This was the second of two inoculations on this vaccine. The first one was on 01/09/2018 in which I only experienced soreness at site of injection and tiredness. The second one on 03/10/2018, in addition to soreness at injection site: chills, fever, exhaustion, body ache in evening; I took 2 ibuprofen and was able to sleep; when I awoke this morning, the chills were gone, but still had exhaustion, body ache, plus nausea and depression.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This was the second of two inoculations on this vaccine. The first one was on 01/09/2018 in which I only experienced soreness at site of injection and tiredness. The second one on 03/10/2018, in addition to soreness at injection site: chills, fever, exhaustion, body ache in evening; I took 2 ibuprofen and was able to sleep; when I awoke this morning, the chills were gone, but still had exhaustion, body ache, plus nausea and depression.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Acne, Ageusia, Anosmia, Flatulence, Functional gastrointestinal disorder
Clinical narrative: The day after I got the vaccine my tongue started hurting. I had never had that before. My tongue turned black for months. I had to clean my tongue for two months, then my tongue turned white and now I still have to clean my tongue every morning. My large intestine stopped working for the first time in my life. Food was going right through my intestines as soon as I ate - I would hear liquid bubbling sounds and then had extreme gas for months as my lower intestine had to digest all of my food. I am getting huge lumps on my face. I get very painful lumps that spread out over half of my forehead and when they start to go down the gland on the left side of my neck swells up so badly it makes the side of my face stick out. I have a huge new lump on my forehead today and another painful lump on the side of my face near my ear. I also have problems with acne, I'm 60 years old and had not had problems with acne for many years. My large intestine is starting to work now but I have the huge painful facial lumps and some tongue pain still and have to clean my tongue every day. I also lost my sense of smell and taste the day after the vaccine injection.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Gastrointestinal hypermotility, Glossodynia, Mass, Pain, Swelling
Clinical narrative: The day after I got the vaccine my tongue started hurting. I had never had that before. My tongue turned black for months. I had to clean my tongue for two months, then my tongue turned white and now I still have to clean my tongue every morning. My large intestine stopped working for the first time in my life. Food was going right through my intestines as soon as I ate - I would hear liquid bubbling sounds and then had extreme gas for months as my lower intestine had to digest all of my food. I am getting huge lumps on my face. I get very painful lumps that spread out over half of my forehead and when they start to go down the gland on the left side of my neck swells up so badly it makes the side of my face stick out. I have a huge new lump on my forehead today and another painful lump on the side of my face near my ear. I also have problems with acne, I'm 60 years old and had not had problems with acne for many years. My large intestine is starting to work now but I have the huge painful facial lumps and some tongue pain still and have to clean my tongue every day. I also lost my sense of smell and taste the day after the vaccine injection.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Tongue discolouration, Trichoglossia
Clinical narrative: The day after I got the vaccine my tongue started hurting. I had never had that before. My tongue turned black for months. I had to clean my tongue for two months, then my tongue turned white and now I still have to clean my tongue every morning. My large intestine stopped working for the first time in my life. Food was going right through my intestines as soon as I ate - I would hear liquid bubbling sounds and then had extreme gas for months as my lower intestine had to digest all of my food. I am getting huge lumps on my face. I get very painful lumps that spread out over half of my forehead and when they start to go down the gland on the left side of my neck swells up so badly it makes the side of my face stick out. I have a huge new lump on my forehead today and another painful lump on the side of my face near my ear. I also have problems with acne, I'm 60 years old and had not had problems with acne for many years. My large intestine is starting to work now but I have the huge painful facial lumps and some tongue pain still and have to clean my tongue every day. I also lost my sense of smell and taste the day after the vaccine injection.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Patient stated that he is experiencing pain in his left arm. He states the pain began after the immunization and he is still experiencing discomfort. Referred patient to his family physician if the pain continued.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Very swollen lymph nodes under right arm, axillary (armpit) area, Pain in right arm and underarm.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Patient experienced headache night of. Patient started experiencing extreme muscle pain in 24 hours as well as chills and fatigue.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Eye movement disorder, Nervous system disorder, Pyrexia
Clinical narrative: Per mom, pt had fever to 101 degrees, inconsolable crying with eyes rolling back and crossing along with pt sticking her tongue out after immunizations done at 2, 4 and 6 months, but mom did not inform me until about the 9 month checkup. The neurological events would last a few minutes and resolve.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia, Somnolence
Clinical narrative: Fever, tiredness/sleepiness, shakes, headache, pain at injection site. Lasted about 40 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Fever, tiredness/sleepiness, shakes, headache, pain at injection site. Lasted about 40 hours.
Age: 77.0
Sex: M
Vaccine: TYP
Symptoms: Blood urea increased, Chills, Headache, Malaise, Myalgia
Clinical narrative: Headache began 32 hours after the 1st dose. Followed by muscle aches and pain and malaise over the next 48 hours. Then fever (Temp 102 oral) and shaking chills. At this point I sought help.
Age: 77.0
Sex: M
Vaccine: TYP
Symptoms: Pain, Pyrexia, Shift to the left, Streptococcus test positive, Tremor
Clinical narrative: Headache began 32 hours after the 1st dose. Followed by muscle aches and pain and malaise over the next 48 hours. Then fever (Temp 102 oral) and shaking chills. At this point I sought help.
Age: 77.0
Sex: M
Vaccine: TYP
Symptoms: White blood cell count increased
Clinical narrative: Headache began 32 hours after the 1st dose. Followed by muscle aches and pain and malaise over the next 48 hours. Then fever (Temp 102 oral) and shaking chills. At this point I sought help.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Diarrhoea, Erythema, Fatigue, Feeding disorder
Clinical narrative: The patient is a 54 year old in the ED for fever, chills, inability to tolerate PO solids (able to tolerate fluids), diarrhea, fatigue. Recently received PREVNAR vaccine (4 days ago), after which he developed the above symptoms, as well as left arm redness/swelling, tenderness. Clindamycin 600 mg QID, Piperacillin/tazobactam 3.375 mg once.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: The patient is a 54 year old in the ED for fever, chills, inability to tolerate PO solids (able to tolerate fluids), diarrhea, fatigue. Recently received PREVNAR vaccine (4 days ago), after which he developed the above symptoms, as well as left arm redness/swelling, tenderness. Clindamycin 600 mg QID, Piperacillin/tazobactam 3.375 mg once.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle twitching
Clinical narrative: Patient reported twitching in arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Abdominal pain upper, Blood glucose decreased, Blood test normal, Burning sensation, Cerebellar ataxia
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Computerised tomogram normal, Constipation, Dizziness, Dysarthria, Ear pain
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Fatigue, Gait inability, Haematochezia, Headache, Hyperaesthesia
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Hypoaesthesia, Nausea, Neck pain, Neurological examination abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Otitis externa, Pain in extremity, Pain in jaw, Paraesthesia, Sinusitis
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Urine analysis normal, Vertigo, Viral infection, Wheelchair user
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Abdominal pain upper, Areflexia, Back pain, Blood test normal, Computerised tomogram normal
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Ear pain, Gait inability, Headache, Lumbar puncture normal, Malaise
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Nausea, Neck pain, Neurological symptom, Nuclear magnetic resonance imaging normal, Posture abnormal
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Sensory loss, Vertigo, Wheelchair user
Clinical narrative: After my daughter's second GARDASIL shot she became ill 21 days after. Ear pain, head pain, stomach pain. On Jan 26th she could not walk at all. She has been hospitalized 4 times already. She suffers neurological symptoms now. She can't feel her legs or feet. She is still in wheelchair. She suffers from vertigo, nausea, headaches, back and neck pain, can't hold her head up. Leg reflexes are gone.
Age: 60.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: 6 inch raised area, with redness, and warm to touch, Patient noted as well having a Fever.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: Student presented with headache and fever of 101.9F at around 2:30pm the day after receiving her 3rd HPV. 650mg of Tylenol provided and fever decreased after 1 hour of observation.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT).   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT).   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose M-M-R II, lot # N025889, expiration date 18-APR-2019, 0.5 ml, subcutaneous for prophylaxis. The M-M-R II was reconstituted with an improperly stored sterile diluent, lot # N026287, expiration date 07-FEB-2020. No adverse effects were reported. Names of vaccines involved: M-M-R II. Temperature/Time frame: 9-25 Celsius degrees for 8 hours 42 minutes, and 9-25 Celsius degrees for 2 hours 50 minutes. Previous temperature excursion? NO. Was call because of a "data logger"? YES.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 17-NOV-2016 and 27-JAN-2017, the patient was vaccinated with the first and second dose of GARDASIL 9 (lot # and expiration date unknown), intramuscularly as prophylaxis. On 04-APR-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # reported as M0411213 and expiration date reported as 22-JUN-2019), intramuscularly as prophylaxis (administered too early, inappropriate schedule of drug administration). No adverse effects were reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Anaphylactic shock, Cough, Rash, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 5-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 27-FEB-2018, the patient was vaccinated with the second dose of PROQUAD injection via subcutaneous route lot # N025929 with expiration date on 18-MAR-2018 as a five year immunization against measles, mumps, rubella and varicella, reconstituted with sterile diluent (MERCK STERILE DILUENT). On the same day, at the physician's office, the patient experienced an anaphylactic shock further described as coughing, vomiting, and breaking out in a rash and hives. The patient was treated with epinephrine, diphenhydramine hydrochloride (BENADRYL) and unspecified oral steroids. He was observed in the office for two and a half hours, recovered from the event and was able to go home. The relatedness between the event and PROQUAD was not reporter. The event was considered to be life threatening.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 20 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-FEB-2018, the patient was vaccinated with one pediatric dose of VAQTA injection 25/0.5, lot # N019924, expiration date on 02-SEP-2018, for prophylaxis (route of administration was not reported); instead of the recommended adult dose. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a othemedical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 22-FEB-2018, the patient was vaccinated with M-M-R II lot # N020926, expiration date on 01-AUG-2019, for prophylaxis (strength, dose, and route of administration were not reported) which was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) lot #L012345, expiration date on 23-JAN-2018 (strength, dose, and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: HPVX
Symptoms: Disturbance in attention
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient (child of reporter's friend) of unknown age or gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of either GARDASIL 9 or GARDASIL for vaccination. Dosing details, lot # and expiry date were not reported. On an unknown date, 2 weeks after onset of therapy, the patient experienced loss of concentration and focus at school. It was reported that the child was not a patient of the physician. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous report was received from the patient's husband regarding a 20 year old female patient. Patient had no drug reactions/allergies. Information on pertinent medical history and concomitant medications were not reported. On 20-FEB-2018, the patient received GARDASIL 9 at an unspecified ob-gyn medical office to avoid hpv (prophylaxis) (dosing details were not reported). On 27-FEB-2018, the patient found out that she was pregnant through an unspecified pregnancy test. Last menstrual period was 15 through 20, January 2018. Patient did not seek any medical attention. The reporter stated that he was uncomfortable providing information. No product quality complaint (PQC) was present.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 10-JUN-2013, the patient was vaccinated with first dose of GARDASIL (Lot unknown, Expiry date unknown) for prophylaxis. The nurse reported the patient received her second dose of  GARDASIL 9 (Lot unknown, Expiry date unknown) on 21-NOV-2016 at 19 years of age (inappropriate schedule of drug administration)(interchange of vaccine products) and received her third dose of GARDASIL 9 (Lot unknown, Expiry date unknown) on 25-JAN-2017 at 19 years of age. No adverse effects were reported. No additional information provided.