chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Laboratory test, Rheumatoid arthritis
Clinical narrative: Traveled in July and per mom reports, she states that child was in the hospital for a few days due to temporary rheumatoid arthritis. Mom never notified this office when child had a reaction so everything from mom was word of mouth.
Age: 44.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site bruising, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: STIFF NECK ON BODY SIDE OF SHOT BASE OF NECK, SMALL BRUISE AT INJECTION SITE, SHOULDER STIFFNESS ON SIDE OF SHOT.
Age: 25.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Body temperature increased, Miliaria, Pain in extremity
Clinical narrative: Beginning 8/1/16 c/o rash on neck face, feet, chest at back-appeared like a prickly heat rash. C/O temp ranging from 99-100 pain in feet.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Mouth ulceration, Vaginal ulceration
Clinical narrative: Oral/vaginal ulcers-recurrent since shortly after 1st HPV-has seen numerous specialists-on Colchicine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Patient reported having headache, nausea and dizziness x 12 hr. after 1st dose of vaccine. Resolved without treatment.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash erythematous, Scab
Clinical narrative: Fever, Tmax 102.7 rash starting with small red bumps that turned to blisters then popped and crusted.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure decreased, Gaze palsy, Pallor, Tremor
Clinical narrative: Patient received TDAP, MENACTRA, and HPV vaccine today. HPV was administered last. Almost immediately after the injection, he became pale, had a fixed gaze, and his arms an upper body shook. The episode lasted approximately 2 seconds. There was no LOC. His BP went down from 99/60 to 76/33, but after resting for 5 min and drinking 2 cups of water it went up to 96/63, HR 55 - all NNL
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Deltoid red and sl tender but resolving per mom.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Initial insomnia, Oral discomfort, Oral mucosal blistering, Oral pain
Clinical narrative: The night following the vaccination I was unable to fall asleep without my thoughts wondering (uncontrollably). This happened for about 2-3 days. A couple of days after the roof of my mouth was very sore and I started to get blisters in that area like it was burned.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Chest X-ray, Intensive care, Respiratory distress, Wheezing
Clinical narrative: Within 4 minutes of receiving MMR, onset respiratory distress, wheezing, EPIPEN administered to right thigh. Sent to ER for resp. treatment and ICU for observation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: (L) arm swelling, itching, sore, lot of discomfort.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Mass, Nodule, Pyrexia
Clinical narrative: Started out as red nodule on Friday, 8.5 and then grew to 4-6 cm lump appeared, size of walnut on Sat, Aug 6.  Tender and hot to touch; mild fever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Started out as red nodule on Friday, 8.5 and then grew to 4-6 cm lump appeared, size of walnut on Sat, Aug 6.  Tender and hot to touch; mild fever.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Child and guardian did not speak the language, uncle was assisting family.  When uncle was asked to identify child, he gave the wrong name.  Patient was given Pediarix instead of Tdap, IPV, HBV. Later identified during sister's turn for vaccines.  MCIR was corrected.  No identifiable reaction by patient.
Age: 17.0
Sex: F
Vaccine: MENB, TTOX
Symptoms: Dizziness, Seizure, Syncope
Clinical narrative: Patient received Bexsero and upon administration felt light headed and dizzy. Then the patient fainted and started to convulse. This only lasted for less than a minute then the patient woke up.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hypoacusis, Paraesthesia, Vision blurred
Clinical narrative: Lightheaded, blurry vision, decreased hearing. 24-36h later, had some tingling in the arms. Was seen @ an urgent care facillity.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Fall, Head injury, Syncope
Clinical narrative: On 8/8/2016, pt received the Gardasil 9 vaccine. Pt was fine immediately after shots and walked to the checkout counter with no issues. About 5 minutes after vaccination, pt experienced a syncope episode at the checkout window. When nurse checked on pt he was coming back around and responsive. Pt was able to follow commands and sit up on his own. Pt drank a cup of water and ate a granola bar without difficulty. Pt was moved into an exam room where Dr. examined him. She noted no abnormalities at that time, but mom was concerned because he hit his head when he fell. She had pt stay for 15 minutes longer and then reassessed. Mom was concerned at that point because pt could not remember anything around the time of the syncopal episode. Mom stated she wanted to take pt to the ER to be further evaluated. Dr. informed her that loss of memory is common with syncope, but she could take him to the ER if that would make her more comfortable.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Head injury, Loss of consciousness, Syncope
Clinical narrative: Syncope - loss of consciousness for 45-60 seconds - possible seizure activity- labored breathing. Struck head on half wall and chair before falling on floor. Paramedics called but pt regained consciousness and mother refused transport to hospital.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal operation, Abnormal behaviour, Barium enema, Emotional distress, Enema administration
Clinical narrative: My 5 month old woke up screaming, kicking, pinching, Unconsolable. Second bowel movement had blood, I saw bowel at his rectum, taken immediately to Hospital. Diagnosed as intussusception. Failed barium enema, emergent exploratory laparoscopic surgery to correct. Day 2 of hospitalization, reoccurrence with a successful barium enema to correct. 4 days hospitalization with antibiotics flatly and rocephin given. No lead points or etiology visualized during his surgery. Otherwise perfectly healthy, robust and thriving for his age.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Laparoscopic surgery, Screaming, Ultrasound abdomen abnormal
Clinical narrative: My 5 month old woke up screaming, kicking, pinching, Unconsolable. Second bowel movement had blood, I saw bowel at his rectum, taken immediately to Hospital. Diagnosed as intussusception. Failed barium enema, emergent exploratory laparoscopic surgery to correct. Day 2 of hospitalization, reoccurrence with a successful barium enema to correct. 4 days hospitalization with antibiotics flatly and rocephin given. No lead points or etiology visualized during his surgery. Otherwise perfectly healthy, robust and thriving for his age.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Abdominal pain, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: L thigh swelling, erythema, warm, painful, and itching.  Erythema rapidly increased throughout the day. At clinic at 5:40 p.m. 10x8 cm.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came in 4 days after vaccine with an rx for an antibiotic to help with rxn.  Area looked red and swallowen to most of deltoid area on left arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Electrocardiogram normal, Injection site pain, Neck pain, Neuralgia
Clinical narrative: Received shingles shot on 7/28.  By 7/29 unbelievable pain on left side of arm where shot administered from neck, shoulder, arm and hand.  Reported to pharmacy on 8/1.  Said I was having an adverse reaction to shingles shot.  Went to emergency room on 8/4.  Took 8 vials of blood, gave me ekg because left side-everything negative.  Gave me steroids and pain meds.,  Pain did not abate, went to my doctor's office on 8/5, for excruciating pain. Pain has been debilitating.  i am currently on neurotin and pain meds, hot and cold compresses, massage and pain patches.  It has almost been two weeks.  I feel like I have the nerve pain after someone has experienced shingles.  It has been debilitating and I wonder when it will end. Iwill probably go back to doctors by next week if I do not see significant improvement in function and pain.  All over a shingles shot!!!!!!!!
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Received shingles shot on 7/28.  By 7/29 unbelievable pain on left side of arm where shot administered from neck, shoulder, arm and hand.  Reported to pharmacy on 8/1.  Said I was having an adverse reaction to shingles shot.  Went to emergency room on 8/4.  Took 8 vials of blood, gave me ekg because left side-everything negative.  Gave me steroids and pain meds.,  Pain did not abate, went to my doctor's office on 8/5, for excruciating pain. Pain has been debilitating.  i am currently on neurotin and pain meds, hot and cold compresses, massage and pain patches.  It has almost been two weeks.  I feel like I have the nerve pain after someone has experienced shingles.  It has been debilitating and I wonder when it will end. Iwill probably go back to doctors by next week if I do not see significant improvement in function and pain.  All over a shingles shot!!!!!!!!
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Nausea, Vomiting
Clinical narrative: DIZZINESS, NAUSEA, VOMITING, COLD SWEAT WITHIN 15 MINUTES OF INJECTION.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Eye movement disorder, Fall, Incoherent, Tremor
Clinical narrative: Fell from seated position off exam table, was shaking on the floor. Eyes were rolling back. Speech was incoherent. Nurse gave ice pack under neck and had him lay down.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient reports severe injection site reaction with swelling, redness and hardening of injection site.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse concerning to a currently 25 year old female patient. There were no pertinent medical history, drug reactions and allergies. On 06-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9, via intramuscularly route, (lot number L019287, with an expiration date of 14-SEP-2017) (strength, dose and anatomical location were not reported), and on 06-JUN-2016, she was vaccinated with the second dose of GARDASIL 9, via intramuscular route (lot number L019287, with an expiration date of 14-SEP-2017) (strength, dose and anatomical location were not reported). The patient was not taking concomitant medications. On an unknown date, the patient became pregnant with an estimated date of last menstrual period (LMP) and 06-JUN-2016 and estimated due date (EDD) of 13-MAR-2017. The nurse stated that the patient was currently 8 weeks pregnant that was confirmed by an "at home pregnant test" on an unspecified date in 2016. At the time of reporting, the pregnancy outcome was pending. No product quality compliance (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Eye movement disorder, Face injury, Fall
Clinical narrative: Pt. fainted about 1 minute after receiving vaccines. -Patient fell from exam table on to the floor hit head and face, eyes rolled back and looked like he was having a seizure, rolled him to a side until he recovered 5 min later, he stated he felt ok. We did an EKG, was sent to cardio, and sent to do a CT of the Brain. I gave patient his vaccines (3) that were ordered, asked the patient if he was ok afterwards he said yes. I stepped out of the room and was walking away when I heard a noise of chairs bumping against the wall and the child's mom asking for help. I ran back to the room and saw the child on the floor having what looked like a minor seizure. I held him and turned him on to his left side and just told the mom not to worry while called doctor, the child then gained consciousness and his color came back, we gave him water and doctor took over the consultation. (Pt's mom states he fell on his face). I ran back to the room when I saw the child was having what looked like a seizure, I layed him on his left side and told one of the other MA's to call doctor. I calmed the mom down and explained it happens with certain patients but he would be ok. We brought him water and leaned him against the wall, then doctor came in and took over the office visit.  Patient was ordered and X-ray and a CT scan of the Brain to make sure he is ok. Also and EKG was done and he was referred to Pediatric cardiology to rule out anything else that could have caused him fainting.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Head injury, Loss of consciousness, Seizure like phenomena, Skin discolouration, Spinal X-ray normal
Clinical narrative: Pt. fainted about 1 minute after receiving vaccines. -Patient fell from exam table on to the floor hit head and face, eyes rolled back and looked like he was having a seizure, rolled him to a side until he recovered 5 min later, he stated he felt ok. We did an EKG, was sent to cardio, and sent to do a CT of the Brain. I gave patient his vaccines (3) that were ordered, asked the patient if he was ok afterwards he said yes. I stepped out of the room and was walking away when I heard a noise of chairs bumping against the wall and the child's mom asking for help. I ran back to the room and saw the child on the floor having what looked like a minor seizure. I held him and turned him on to his left side and just told the mom not to worry while called doctor, the child then gained consciousness and his color came back, we gave him water and doctor took over the consultation. (Pt's mom states he fell on his face). I ran back to the room when I saw the child was having what looked like a seizure, I layed him on his left side and told one of the other MA's to call doctor. I calmed the mom down and explained it happens with certain patients but he would be ok. We brought him water and leaned him against the wall, then doctor came in and took over the office visit.  Patient was ordered and X-ray and a CT scan of the Brain to make sure he is ok. Also and EKG was done and he was referred to Pediatric cardiology to rule out anything else that could have caused him fainting.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt. fainted about 1 minute after receiving vaccines. -Patient fell from exam table on to the floor hit head and face, eyes rolled back and looked like he was having a seizure, rolled him to a side until he recovered 5 min later, he stated he felt ok. We did an EKG, was sent to cardio, and sent to do a CT of the Brain. I gave patient his vaccines (3) that were ordered, asked the patient if he was ok afterwards he said yes. I stepped out of the room and was walking away when I heard a noise of chairs bumping against the wall and the child's mom asking for help. I ran back to the room and saw the child on the floor having what looked like a minor seizure. I held him and turned him on to his left side and just told the mom not to worry while called doctor, the child then gained consciousness and his color came back, we gave him water and doctor took over the consultation. (Pt's mom states he fell on his face). I ran back to the room when I saw the child was having what looked like a seizure, I layed him on his left side and told one of the other MA's to call doctor. I calmed the mom down and explained it happens with certain patients but he would be ok. We brought him water and leaned him against the wall, then doctor came in and took over the office visit.  Patient was ordered and X-ray and a CT scan of the Brain to make sure he is ok. Also and EKG was done and he was referred to Pediatric cardiology to rule out anything else that could have caused him fainting.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis contact
Clinical narrative: This spontaneous report concerning a patient of an unknown gender and age was received from a medical assistant. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, lot and expiration date were not provided). There were no concomitant medications reported. On an unknown date, the patient experienced a bad case of poison ivy (dermatitis contact). No product quality complaint was involved. At the time of reporting, the outcome of the event of dermatitis contact was unknown. The causality between ZOSTAVAX and the event of dermatitis contact was not assessed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician assistant referring to multiple unspecified patients of unknown age and gender. The pertinent medical history and concomitant therapy of the patients were not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (lot #, dose frequency and route were unspecified). An unspecified time after receiving ZOSTAVAX, these patients developed shingles. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patients concurrent condition, medical history and concomitant therapy were not provided. On an unknown date (reported as "several years ago"), the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, strength, dose, route and frequency unknown). On 03-AUG-2016, the patient was vaccinated dose two with GARDASIL 9 injection (lot number, expiration date, strength, dose, route and frequency unknown). No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Information has been received from a 45 year old female patient, via Pfizer (Source Document # 2016366565), concerning herself. The patient's concurrent conditions included diabetes mellitus, fibromyalgia, osteoarthritis, sacroiliitis , anxiety, depression and sleep disorder. The patient's medical history was not reported. On 27-JUL-2016 at 17:00, the patient was vaccinated with the first dose of PENUMOVAX23 (lot #, expiration date, concentration, dose and route were not reported) in the left arm by a nurse. Concomitant therapies included metformin (lot #, expiration date and concentration were not reported), 1000 mg twice a day per oral route for diabetes; gabapentin (lot #, expiration date and concentration were not reported), 600 mg twice a day per oral route for fibromyalgia; CYMBALTA (lot #, expiration date and concentration were not reported), 30 mg once a day per oral route for fibromyalgia anxiety and depression; and trazodone hyrodchloride (lot #, expiration date and concentration were not reported), 50 mg at night per oral route for sleep. The patient reported that on 27-JUL-2016, between 22:00 and 23:00, she could not move her arm without incredible pain and it hurt so bad that she could not stand it. The patient stated that her arm was sore right after the injection and the pain progressively got worse as the night went on. She said that her arm became warm and swollen about 6 hours after received the injection. The patient stated that it had affected the range of motion, so she could barely pick up her elbow even with her shoulder. She took an ibuprofen 600 mg on 28-JUL-2016 and  her arm was still hurting through that and she was thinking about going to the doctor this same day. There were no laboratory diagnostic tests performed. The patient also reported that she was diabetic and her physician wanted to give her PNEUMOVAX23 to protect her and the physician said she would not need another one until she was 65 years old. The outcome of patient can not move her arm without incredible pain, her arm was sore right after the injection, her arm became warm, swollen, red and the patient can barely pick up her elbow with her shoulder was reported as not recovered. There was not product quality complaint (PQC) involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a 45 year old female patient, via Pfizer (Source Document # 2016366565), concerning herself. The patient's concurrent conditions included diabetes mellitus, fibromyalgia, osteoarthritis, sacroiliitis , anxiety, depression and sleep disorder. The patient's medical history was not reported. On 27-JUL-2016 at 17:00, the patient was vaccinated with the first dose of PENUMOVAX23 (lot #, expiration date, concentration, dose and route were not reported) in the left arm by a nurse. Concomitant therapies included metformin (lot #, expiration date and concentration were not reported), 1000 mg twice a day per oral route for diabetes; gabapentin (lot #, expiration date and concentration were not reported), 600 mg twice a day per oral route for fibromyalgia; CYMBALTA (lot #, expiration date and concentration were not reported), 30 mg once a day per oral route for fibromyalgia anxiety and depression; and trazodone hyrodchloride (lot #, expiration date and concentration were not reported), 50 mg at night per oral route for sleep. The patient reported that on 27-JUL-2016, between 22:00 and 23:00, she could not move her arm without incredible pain and it hurt so bad that she could not stand it. The patient stated that her arm was sore right after the injection and the pain progressively got worse as the night went on. She said that her arm became warm and swollen about 6 hours after received the injection. The patient stated that it had affected the range of motion, so she could barely pick up her elbow even with her shoulder. She took an ibuprofen 600 mg on 28-JUL-2016 and  her arm was still hurting through that and she was thinking about going to the doctor this same day. There were no laboratory diagnostic tests performed. The patient also reported that she was diabetic and her physician wanted to give her PNEUMOVAX23 to protect her and the physician said she would not need another one until she was 65 years old. The outcome of patient can not move her arm without incredible pain, her arm was sore right after the injection, her arm became warm, swollen, red and the patient can barely pick up her elbow with her shoulder was reported as not recovered. There was not product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received from a medical assistant (also reported as office manger) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates between 2009-2011, the patient received 3 doses of GARDASIL (dose, frequency, route, lot # and expiration date unknown). The patient was inadvertently administered an additional dose of GARDASIL injection (lot # K006124, expired on 02-FEB-2017) (dose and route unknown) in 06-DEC-2014 and another additional dose (lot # K011325, expired date 08-APR-2017) (dose and route unknown) on 12-MAY-2016. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, and refers to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 04-AUG-2016, the patient was vaccinated with an improperly stored VARIVAX (lot # M000996, expiration date 07-JAN-2018 (concentration, dose and administration route were not reported). The patient's concomitant medication was not provided. Additionally, No adverse reactions were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Product use issue
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, subcutaneously, that according to the patient the healthcare provider did not immediately administered the vaccine after reconstitution. The patient stated they were concerned as the vaccine was left out at room temperature for 40 minutes before being given (product use issue) (dose number, dose, frequency, lot number and expiration date). No product quality complaint (PQC) was involved. Concomitant medication was not provided. Finally, the reporter inquired about the stability information for PNEUMOVAX23, as she thought the vaccine may have lost its potency. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) referring to a 12 month old male patient. Pertinent medical history, concurrent conditions, and concomitant therapies were not reported. On 30-MAY-2015, the patient was vaccinated with VARIVAX (lot # H019449, expiration date 25-OCT-2014, 0.5 ml; M-M-R II (lot # H015833, expiration date 24-AUG-2014, 0.5 ml; both subcutaneously and VAQTA (lot # H019104, expiration date: 19-JUL-2015, 0.5 ml, intramuscularly. Dose number and anatomical location were not reported. The Registered Nurse reported that the patient developed hives and sought Medical Attention (unspecified). An unspecified treatment was given for hives. At the time of reporting the outcome of urticarial was unknown. The Registered Nurse stated that the patient, now four years old, had been given his unspecified vaccines individually and had no side effects. The reporter did not provide the causality assessment between the event and the suspect therapies. There was not a product quality complaint involved. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring a 23 years old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PROQUAD injection, 0.5 ml, subcutaneously (lot number and expiration date were not reported). The registered nurse stated that a dose of VARIVAX was suppose to had been administered to the patient, but due to a human error, a dose of PROQUAD was administered; and she wanted to know what adverse effects to monitor. No adverse effects were reported and no product quality complaint was involved. Additional information had been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant referring to 3 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported.  On an unspecified date in AUG-2016 (reported as 02-AUG-2016 or 03-AUG-2016) the patients were vaccinated with improperly stored VARIVAX. Concentration, dose and route of administration were not reported (lots # M000757 and L020002, expiry date 06-FEB-2018 and 02-JAN-2016  respectively). It was reported that the temperature excursion was for 9 hours at 9 F, according to the data logger. There was no previous temperature excursions. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant referring to 3 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date in AUG-2016 (reported as 02-AUG-206 or 03-AUG-2016) the patients were vaccinated with improperly stored PROQUAD. Concentration, dose and route of administration were not reported (lot # M06104, expiry date 01-AUG-2017. It was reported that the temperature excursion was for 9 hours at 9 degrees F, according to the data logger. There was no previous temperature excursions. No symptoms were reported. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Cellulitis, Erythema, Induration, Local swelling, Pruritus
Clinical narrative: Day 1- Day 5 "Became red swollen and itchy (4cm diameter) since then." It stayed like that until 8/6 when she noted it was warm and tender. She examined it at that time and noted that a 2-3 cm portion had become cellulitic in appearance (raised, hard, bumpy, well demarcated) and then there was spreading macular erythema surrounding the lesion. 8/9/16 called to see if improvement. Left message on vm.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Skin lesion, Skin warm, Tenderness
Clinical narrative: Day 1- Day 5 "Became red swollen and itchy (4cm diameter) since then." It stayed like that until 8/6 when she noted it was warm and tender. She examined it at that time and noted that a 2-3 cm portion had become cellulitic in appearance (raised, hard, bumpy, well demarcated) and then there was spreading macular erythema surrounding the lesion. 8/9/16 called to see if improvement. Left message on vm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Rash erythematous
Clinical narrative: Red rashes noted to back/neck and left sided of face. Patient was monitored for 45 minutes with no progression of rash or other discomfort. O2 Sat 98 on RA, HR 96. Patient was alert/talkative prior discharge left in stable condition with mother.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Feeling cold, Tremor
Clinical narrative: Difficulty breathing, shaking, very cold, extreme fatigue.
Age: 17.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Skin warm
Clinical narrative: Patient couldn't describe symptoms but was hot and sweating, she said a little lightheaded. I gave her TYLENOL, cold water and a cold rag for her forehead. She remained seated for approximately 10 to 15 minutes.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Vasovagal syncope. Self recovered after a few hours.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Eye pruritus, Fatigue, Malaise
Clinical narrative: Patient said she felt ill upon getting the flu shot last 8/4/16. She said she has itching all over her body (no rash) and itchy eyes. She also said she felt tired in the evening, off balance, dizziness. She went to the doctor on 8/5/16 and doctor gave her CLARITIN 10 mg and ZADITOR eye drops. She said she felt better now.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Patient said she felt ill upon getting the flu shot last 8/4/16. She said she has itching all over her body (no rash) and itchy eyes. She also said she felt tired in the evening, off balance, dizziness. She went to the doctor on 8/5/16 and doctor gave her CLARITIN 10 mg and ZADITOR eye drops. She said she felt better now.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Swelling face
Clinical narrative: Erythema and buccal swelling, left cheek, onset 18 hours after vaccine. No lip or tongue swelling. No respiratory difficulties.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Chills, Diarrhoea, Dizziness, Full blood count, Headache
Clinical narrative: Nausea, headache, paresthesia fingertips and toes, lightheaded, and crampy, chills, achy (B) testicle, loose stool/diarrhea x3.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Metabolic function test, Muscle spasms, Nausea, Paraesthesia, Testicular pain
Clinical narrative: Nausea, headache, paresthesia fingertips and toes, lightheaded, and crampy, chills, achy (B) testicle, loose stool/diarrhea x3.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Urine analysis
Clinical narrative: Nausea, headache, paresthesia fingertips and toes, lightheaded, and crampy, chills, achy (B) testicle, loose stool/diarrhea x3.
Age: 0.08
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Local swelling, Neck pain, Pain
Clinical narrative: Large swelling on the left side of the neck: it is warm and painful 2 days. After the vaccine she has a sharp pain on the side of neck and numbness and headache.
Age: 0.08
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Large swelling on the left side of the neck: it is warm and painful 2 days. After the vaccine she has a sharp pain on the side of neck and numbness and headache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Limb discomfort, Skin warm, Swelling
Clinical narrative: At presumed PNEUMOVAX  (PPSV-13) site (L) upper arm burning sensation, swelling, welts x 2, warmth and arm discomfort by evening of vaccine. Seen in office with swelling 5 cm erythema and warmth. No urticarial. No fever. Prescribed treatment today 8/9/16.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: At presumed PNEUMOVAX  (PPSV-13) site (L) upper arm burning sensation, swelling, welts x 2, warmth and arm discomfort by evening of vaccine. Seen in office with swelling 5 cm erythema and warmth. No urticarial. No fever. Prescribed treatment today 8/9/16.
Age: 75.0
Sex: M
Vaccine: HEP, HEPA, YF
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Pt describes body aches, sore throat, congestion. Reaction reported to this provider on 8-9-16, states he is feeling better.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Erythema, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: On night of receiving vaccines, patient noticed that both arms were red, swollen to about the size of a golf ball, and itching at the injection site. She had taken and continues to take BENADRYL and ibuprofen with minimal relief. On 08/01/16 she state that swelling and itching is still present. She also describes pain in joints in arm near elbow. At this time, patient has not seen a physician.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Headache, Nausea, Pyrexia, Skin warm
Clinical narrative: Had a fever, headache, nausea, arm feels warm and redness. Given left deltoid. Intramuscular. TRUMEMBA MVC13 first dose. Temperature 100.3. Patient noticed on 7/27/16 around 10:00pm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Diarrhoea, Urticaria
Clinical narrative: 30 minutes after vaccines, patient developed urticaria of (L) limb, diarrhea.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom in clinic today. Reports LA (TDAP) site swelled, warm to touch and sore with itching. Started Saturday 7/30/16.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site hypoaesthesia, Pain in extremity, Syncope
Clinical narrative: Syncope instantly after injection. Questionable seizure. 24 hrs later, patient complained of numbness at injection site, unable to verbalize or move for several minutes. Persistent arm pain.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt. came to the pharmacy so we could check her arm. Her arm appeared extremely red, swollen and warm. Pt. also stated her arm was itching. I recommended she use some hydrocortisone cream and BENADRYL, then contact her PCP.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient reported redness, swelling, tenderness and warm to the touch on 8/1/16. Vaccine administered 7/26/16. Patient was told to contact physician to schedule appointment. Patient stated physician determined allergic reaction. Use BENADRYL for the treatment necessary.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Arm which vaccine was administered became red, hot and swollen. Swelling went below elbow and above shoulder and to chest. Patient complained of minor itching and pain. Mother reports similar reaction after patient received 1 year old vaccines.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying, Diarrhoea, Gastroenteritis, Pyrexia, Skin discolouration
Clinical narrative: Low grade temp right after vaccinations. 2 days later vomiting and diarrhea started. Fever still. Pt appeared to parents w/weight loss, poor color and crying. Saw MD on 1/14/15 diagnosed with gastroenteritis and given lactobacillus.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Vomiting, Weight decreased
Clinical narrative: Low grade temp right after vaccinations. 2 days later vomiting and diarrhea started. Fever still. Pt appeared to parents w/weight loss, poor color and crying. Saw MD on 1/14/15 diagnosed with gastroenteritis and given lactobacillus.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Full blood count normal
Clinical narrative: 9 inch diameter redness w/blisters filled w/clear fluid. Started 7/28 and went to ER on 7/30 - given 1gm of ROCEPHIN IM. Then ROCEPHIN 1gm on 7/31. Also on oral antibiotics.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Body was aching, and injection site was sore for 5 days. He said he couldn't lift his arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Tenderness
Clinical narrative: She got rash (size of a hand), pain, tenderness.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Injection site vesicles, Pain, Tenderness
Clinical narrative: Vaccine given 7/26/16, subsequently presented with Redness, Tenderness, same ache/pain a day or 2 after injection. This later advanced to small Blister at site of Injection.
Age: 81.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Local swelling, Peripheral swelling, Pruritus
Clinical narrative: After receiving both vaccinations on 7/14/16. ZOSTAVAX arm had very raised red lengthwise patch up and down back of arm. Then 1 wk later PREVNAR arm began to swell 5" diameter swelling red itchy around arm in a band fashion around arm.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blister, Erythema, Injection site paraesthesia, Injection site warmth
Clinical narrative: 7/21 Pt got tingling at the injection site. It was warm to the touch. A day or 2 later, she got a blister patch on the skin - PT goes to 7/23 clinic - Got 2 antibiotics - red patch reduced to a finger tip size. Blister dry up after 12 days.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Headache, Muscle strain, Nausea, Vomiting
Clinical narrative: Approx 1 1/2 hours after TRUMENBA pt developed severe back pain with nausea, vomiting and a headache. Was taken to ER. DX: Back strain.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope shortly after vaccines given.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient reported via phone on 7/29/16 that he is experiencing severe pain to his right arm which has caused him to reduce the use of it. Provider FNP attempted to follow up with patient via phone. Received no answer and left voice mail message x2. Patient has not returned calls.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia, Streptococcus test negative
Clinical narrative: Patient complained of high fever on 8/7 of 106.4 orally. Left arm at injection site warm, hard, and red at the back of arm where PROQUAD was given sub. Q fever went down 8/8, patient was seen 8/8 by Dr. Patient was given MOTRIN for fever.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood thyroid stimulating hormone, Echocardiogram, Electrocardiogram normal, Full blood count, Laboratory test normal
Clinical narrative: Syncope episodes x 2 1 wk after shot.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Liver function test, Metabolic function test, Syncope
Clinical narrative: Syncope episodes x 2 1 wk after shot.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Pt presented 2 days after Tdap with cellulitis right upper extremity, Pt states she first noticed symptoms developing afternoon of injection. Vital signs stable.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt c/o redness, pain, swelling and limited mobility in right deltoid the evening he was vaccinated. Guardian of pt. applied ice for treatment. All symptoms except pain resolved by 7/25/16
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Patient was inadvertently given MMRV instead of MMR; they were next to each other in the fridge and grabbed the wrong one, even though the bottle was checked.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Crying, Dizziness, Muscular weakness, Neck pain
Clinical narrative: Within a few hours, pt. had back and neck pain, crying, giddiness, weakness in her limbs.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Patient lacerated her skin and fractured a finger. She was given BOOSTRIX in ER (Tdap) 7/24/16. She reported for follow up at our office 7/27/16 reporting redness, swelling and feeling feverish/chills. Area where redness and swelling left lateral arm below deltoid mild to moderate redness and swelling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction. Redness, swelling, pain.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Loss of consciousness, Muscle twitching
Clinical narrative: Patient had a episode of brief loss of consciousness, with involuntary twitch/movement of extremities, following administration of 2nd HPV vaccine. Recovered slowly, 30 min. observation.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Malaise, fatigue, fever starting a few hours after vaccination.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Chills, Fatigue
Clinical narrative: Malaise, fatigue, fever starting a few hours after vaccination.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema
Clinical narrative: 9 1/2 cm x 7 cm Erythema left thigh.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Feeling cold, Oropharyngeal pain, Paranasal sinus hypersecretion, Respiratory tract congestion
Clinical narrative: Sinus running, sore throat, chills, achy joints, chest mucous. Lasted from 20-July till 28 July. Called hospital RN said it would last 4 to 6 days. Still got chest mucous.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPAB, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I mistaken pulled a vaccine from TWINRIX box, when should have pulled from KINRIX box. Vaccine administered to pt. No adverse reaction. Pt was given KINRIX before leaving clinic as mistake was discovered right after administration.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Dizziness - one half hour after injection. Nausea - lasted 3 hours (severe). Headache - dizziness lasted (7) days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling and minor discomfort to right thigh. Rx. diphenhydramine 12.5mg/5ml.
Age: 51.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. Grabbed Ped/Adol. dose instead of Adult. Called pt. to come in and get 2nd half of dose. Ped/Adol. (0.5 ml) - Adult (1 ml)/Pt. Will return for 2nd dose between 8/1/16 - 8/5/16.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Barrett's oesophagus, Bipolar disorder, Chest pain, Deafness unilateral
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old daughter. The patient's medical history included ear infections, when she was a baby and the patient was allergic to nickel. On 11-JAN-2010, the patient was vaccinated with GARDASIL, intramuscularly (dose details, anatomical location, lot number and expiration date were not reported). Concomitant therapies included MENACTRA, DTAP, VARIVAX and 3 other vaccinations. On 31-MAR-2010, the patient experienced unilateral deafness, suicidal thoughts, shortness of breath and rashes. On the same day, the patient was also diagnosed as being bipolar, had Barrett's oesophagus, vomits blood, lost weight, experienced chest pain, back pain and her heart races. The patient vomited her meals up daily. On an unknown date, endoscopy, gastrointestinal (GI) study and many other unspecified tests were performed and results were not reported. The patient sought medical attention and was treated for the adverse events. Therapy with GARDASIL was discontinued on 19-NOV-2010. It was reported that the events reappeared after reintroduction of the vaccine. The outcome of the events was reported as not recovered (reported as did not improve). The causality of the events was not reported. No product quality complaint was reported for GARDASIL. Upon internal review, the events of unilateral deafness, vomits blood, bipolar and Barrett's oesophagus were considered as medically significant. The reporter considered deafness as serious due to disability. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Endoscopy, Haematemesis, Laboratory test, Palpitations
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old daughter. The patient's medical history included ear infections, when she was a baby and the patient was allergic to nickel. On 11-JAN-2010, the patient was vaccinated with GARDASIL, intramuscularly (dose details, anatomical location, lot number and expiration date were not reported). Concomitant therapies included MENACTRA, DTAP, VARIVAX and 3 other vaccinations. On 31-MAR-2010, the patient experienced unilateral deafness, suicidal thoughts, shortness of breath and rashes. On the same day, the patient was also diagnosed as being bipolar, had Barrett's oesophagus, vomits blood, lost weight, experienced chest pain, back pain and her heart races. The patient vomited her meals up daily. On an unknown date, endoscopy, gastrointestinal (GI) study and many other unspecified tests were performed and results were not reported. The patient sought medical attention and was treated for the adverse events. Therapy with GARDASIL was discontinued on 19-NOV-2010. It was reported that the events reappeared after reintroduction of the vaccine. The outcome of the events was reported as not recovered (reported as did not improve). The causality of the events was not reported. No product quality complaint was reported for GARDASIL. Upon internal review, the events of unilateral deafness, vomits blood, bipolar and Barrett's oesophagus were considered as medically significant. The reporter considered deafness as serious due to disability. Additional information has been requested.