chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Pneumonia, Pyrexia, Red blood cell count normal, Rhinorrhoea, Somnolence
Clinical narrative: 9/21/13 fever 100.2, stomach pain. 9/22/13 - 10/10/13 - very sleepy, several naps, not active. 9/26/13 - not feeling well, runny nose no fever. 10/7/13 - sent home from school, fever 100.1. 10/9/13 - sent home from school, can't stay awake, uneasy on feet. 10/9/13 - went to primary care seen nurse practitioner. Labs (mono, strep, WBC, RBC) negative results. Sent home. 10/10/13 - no fever, unable to walk, unable to stand, unable to sit up without falling, balance off, not talking much. Took to ER. Seen Dr. Lab work, urine sample, nasal sample, EKG, chest x-ray (pneumonia), CT head (normal), spinal tap (fluid not clear). Admitted to hospital. 10/11/13 - ran on IV fluids and antibiotics for pneumonia. Received a call from primary care strep (+). 10/12/13 - MRI brain, T-spine, L-spine. Neurologist diagnosed A.D.E.M. Spinal cord inflamed, brain inflamed. Treated with IVIG (5 treatments x1 per day). 10/13/13 - 2nd treatment IVIG. Unable to walk, sit up, tired pain in lower back. 10/14/13 - 3rd treatment IVIG. Able to sit up with little help. OT and PT. 10/15/13 - 4th treatment IVIG. Able to walk with some help, balance still off. 10/16/13 - 5th treatment IVIG. Able to walk with little help, balance off some. OT and PT. 10/17/13 - stable, able to go home, must be under supervision. 10/21/13 - f/u w/neurologist cleared to go to school no restrictions.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Streptococcus test positive, Urine analysis, White blood cell count normal
Clinical narrative: 9/21/13 fever 100.2, stomach pain. 9/22/13 - 10/10/13 - very sleepy, several naps, not active. 9/26/13 - not feeling well, runny nose no fever. 10/7/13 - sent home from school, fever 100.1. 10/9/13 - sent home from school, can't stay awake, uneasy on feet. 10/9/13 - went to primary care seen nurse practitioner. Labs (mono, strep, WBC, RBC) negative results. Sent home. 10/10/13 - no fever, unable to walk, unable to stand, unable to sit up without falling, balance off, not talking much. Took to ER. Seen Dr. Lab work, urine sample, nasal sample, EKG, chest x-ray (pneumonia), CT head (normal), spinal tap (fluid not clear). Admitted to hospital. 10/11/13 - ran on IV fluids and antibiotics for pneumonia. Received a call from primary care strep (+). 10/12/13 - MRI brain, T-spine, L-spine. Neurologist diagnosed A.D.E.M. Spinal cord inflamed, brain inflamed. Treated with IVIG (5 treatments x1 per day). 10/13/13 - 2nd treatment IVIG. Unable to walk, sit up, tired pain in lower back. 10/14/13 - 3rd treatment IVIG. Able to sit up with little help. OT and PT. 10/15/13 - 4th treatment IVIG. Able to walk with some help, balance still off. 10/16/13 - 5th treatment IVIG. Able to walk with little help, balance off some. OT and PT. 10/17/13 - stable, able to go home, must be under supervision. 10/21/13 - f/u w/neurologist cleared to go to school no restrictions.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: The evening after the shot patient's right arm became swollen and red. Patient applied ice and it got bigger in size. The next day it was hard, warm to the touch and the size of a fist in surface area. Nurse at clinic recommended Ibuprofen and BENADRYL and swelling has gone down.
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Paraesthesia oral, Rash, Rash erythematous, Rash macular
Clinical narrative: Rxn like last yr: neck rash and axilla rash, red, blotchy, hive-like. Took CLARITIN 10mg at 730p 11/4/13. Awoke at 1:40 AM 11/5/13 had tingling/swollen lips; took BENADRYL 25 mg. S/S gradually resolved by the next morning.
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Rxn like last yr: neck rash and axilla rash, red, blotchy, hive-like. Took CLARITIN 10mg at 730p 11/4/13. Awoke at 1:40 AM 11/5/13 had tingling/swollen lips; took BENADRYL 25 mg. S/S gradually resolved by the next morning.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local swelling, Malaise, Pain in extremity
Clinical narrative: Given SQ Varicella in (R) forearm at 1440 on 1 Nov 13. Pt states when she got home, her "hair itched and she didn't feel well". Took 3 BENADRYL and went to bed. Arm swelled up "really huge" and had pain. Alternated heat and cold, and MOTRIN and TYLENOL all weekend. Came in today at 1400, and had 44 x 25 cm red, raised, firm area on (R) arm.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Given SQ Varicella in (R) forearm at 1440 on 1 Nov 13. Pt states when she got home, her "hair itched and she didn't feel well". Took 3 BENADRYL and went to bed. Arm swelled up "really huge" and had pain. Alternated heat and cold, and MOTRIN and TYLENOL all weekend. Came in today at 1400, and had 44 x 25 cm red, raised, firm area on (R) arm.
Age: 1.73
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, VARCEL
Symptoms: Skin lesion
Clinical narrative: > 50 mosquito bite type lesions (no vesicles) on both sides of the body. No itching.  Has continued since Oct 24 for a total of 13 days to date.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain, Pruritus, Skin warm
Clinical narrative: Area became hot within first 1/2 hour.  Upon visual inspection on 11/4/13 area was red, hot, itchy and swollen and painful.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash, Varicella virus test negative, Viral test negative
Clinical narrative: Rash on back and L upper arm, no pain/itching, no vesicles, lasted about 1 month, no fever.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Blood creatinine normal, Flank pain, Neuritis, Pain, Urine analysis normal
Clinical narrative: Left costo-vertebral angle pain with radiation in a dermatomal manner around the flank to the anterolateral abdomen lasting three days. No evidence of Zoster, probable neuritis.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain at injection site has continued.  Currently have limited range of motion.  Doctor diagnosed as tendonitis.  Exercises prescribed are making pain in shoulder/arm worse.  Constant pain in shoulder/arm.  Pain, tingling, numbness radiates down arm and into clavicle.  Have limited ability to lift & use left arm.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Tendonitis
Clinical narrative: Pain at injection site has continued.  Currently have limited range of motion.  Doctor diagnosed as tendonitis.  Exercises prescribed are making pain in shoulder/arm worse.  Constant pain in shoulder/arm.  Pain, tingling, numbness radiates down arm and into clavicle.  Have limited ability to lift & use left arm.
Age: 2.0
Sex: F
Vaccine: BCG
Symptoms: Eye disorder, Headache, Renal disorder, Transfusion, Vomiting
Clinical narrative: Headache, vomiting, Kidney problems, eye problem. Blood transfusion.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever, febrile seizure.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Gout, Inflammation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Onset of sx were swelling and pain of left arm. Pt went to ED 10/12 with worsening swelling and pain, axillary adenopathy and inability of moving arm due to pain. Pt was dx'd with acute inflammatory process following vaccinations and also had dx of gout. She was advised to apply ice, take NSAIDS, and pain medications. Pt recieved Toradol and was given RX for indomethacin and oxycodone. Pt returned to ED on 10/14 for continued sx- markedly pain, swellin gand erythema to the left deltoid area. Sx were moderate to severe. Pt had an IV established, and as advised to continue ibuprofen, and to f/u with PCP in 1-2 days. Pt recieved Bactrim for possible mild cellulitis and had a normal ultrasound of left arm. Pt had OV 10/25 with PCP. Pt's sx had resolved in her arm. PCP advised pt to finish abx and rest.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Local swelling, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Onset of sx were swelling and pain of left arm. Pt went to ED 10/12 with worsening swelling and pain, axillary adenopathy and inability of moving arm due to pain. Pt was dx'd with acute inflammatory process following vaccinations and also had dx of gout. She was advised to apply ice, take NSAIDS, and pain medications. Pt recieved Toradol and was given RX for indomethacin and oxycodone. Pt returned to ED on 10/14 for continued sx- markedly pain, swellin gand erythema to the left deltoid area. Sx were moderate to severe. Pt had an IV established, and as advised to continue ibuprofen, and to f/u with PCP in 1-2 days. Pt recieved Bactrim for possible mild cellulitis and had a normal ultrasound of left arm. Pt had OV 10/25 with PCP. Pt's sx had resolved in her arm. PCP advised pt to finish abx and rest.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Onset of sx were swelling and pain of left arm. Pt went to ED 10/12 with worsening swelling and pain, axillary adenopathy and inability of moving arm due to pain. Pt was dx'd with acute inflammatory process following vaccinations and also had dx of gout. She was advised to apply ice, take NSAIDS, and pain medications. Pt recieved Toradol and was given RX for indomethacin and oxycodone. Pt returned to ED on 10/14 for continued sx- markedly pain, swellin gand erythema to the left deltoid area. Sx were moderate to severe. Pt had an IV established, and as advised to continue ibuprofen, and to f/u with PCP in 1-2 days. Pt recieved Bactrim for possible mild cellulitis and had a normal ultrasound of left arm. Pt had OV 10/25 with PCP. Pt's sx had resolved in her arm. PCP advised pt to finish abx and rest.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Cough, Headache, Myalgia
Clinical narrative: Severe headaches, chills, severe cough, muscle aches/pain, severe extensive rash on the arm/shoulder, weakness. Time course not specified. Patient instructed to seek medical attention from primary care physician.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Severe headaches, chills, severe cough, muscle aches/pain, severe extensive rash on the arm/shoulder, weakness. Time course not specified. Patient instructed to seek medical attention from primary care physician.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site irritation
Clinical narrative: Redness and irritation at injection site that spread outward and around arm starting on 11/4/2013.  As of doctor office visit 11/5/2013 evening all the way around the upper arm just above elbow.  Patient reports no fever or other symptoms at this time, but states she is not able to raise arm more than halfway.
Age: 74.0
Sex: F
Vaccine: HEPA
Symptoms: Anaemia, Arthralgia, Arthritis, C-reactive protein increased, Haemoglobin decreased
Clinical narrative: "Severe flare of arthritis" with pain in shoulders, neck, spine, ribs and hips. Low grade fever. Lab tests showed very elevated C reactive protein and new anemia. Responded to prednisone. Total duration of illness over 2 months.
Age: 74.0
Sex: F
Vaccine: HEPA
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Neck pain, Pyrexia, Spinal pain
Clinical narrative: "Severe flare of arthritis" with pain in shoulders, neck, spine, ribs and hips. Low grade fever. Lab tests showed very elevated C reactive protein and new anemia. Responded to prednisone. Total duration of illness over 2 months.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Idiopathic thrombocytopenic purpura, Laboratory test, Petechiae, Platelet count decreased
Clinical narrative: ITP platelets dropped to less than 40. Petechial rash over arms trunk and legs, with nose bleeds x 2.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Very sore arm, shouler, elbow, radiated down to forearm and hand.  Unable to move arm.  Eventually drowsiness, dizziness which gets worse as day goes on.  Different set of aches daily.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Very sore arm, shouler, elbow, radiated down to forearm and hand.  Unable to move arm.  Eventually drowsiness, dizziness which gets worse as day goes on.  Different set of aches daily.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Hyperhidrosis, Malaise, Neurological examination normal, Pallor
Clinical narrative: Vaccine counseling performed by provider prior to vaccine administration by MA. Pt was alert and oriented. Provider left the room to see the next patient, however, was called back into the room after a few minutes by the MA d/t patient not feeling well after vaccine administration. When provider walked into exam room, pt was seated in a chair, appeared pale and somewhat diaphoretic. Pt stated that she was feeling dizzy and lightheaded. Pt was instructed to take deep breaths and was given a bottle of cold water to drink. Pt then verbalized that she was going to vomit. Pt vomited x 1. Pt then reported that she began to feel much better. Pts coloring returned and the diaphoresis abated. No LOC. Pts father was called to come pick patient up from the clinic. Parent arrived within 10 minutes. Patient and parent instructed to take pt to the ER if any adverse reactions occur after leaving clinic.  PE just prior to pt leaving clinic: CV, Lungs, and Neuro exam all WNL. Vitals taken just prior to patient leaving clinic: WNL. Patient stated that she felt much better and ambulated out of the clinic with her father without difficulty.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Vomiting
Clinical narrative: Vaccine counseling performed by provider prior to vaccine administration by MA. Pt was alert and oriented. Provider left the room to see the next patient, however, was called back into the room after a few minutes by the MA d/t patient not feeling well after vaccine administration. When provider walked into exam room, pt was seated in a chair, appeared pale and somewhat diaphoretic. Pt stated that she was feeling dizzy and lightheaded. Pt was instructed to take deep breaths and was given a bottle of cold water to drink. Pt then verbalized that she was going to vomit. Pt vomited x 1. Pt then reported that she began to feel much better. Pts coloring returned and the diaphoresis abated. No LOC. Pts father was called to come pick patient up from the clinic. Parent arrived within 10 minutes. Patient and parent instructed to take pt to the ER if any adverse reactions occur after leaving clinic.  PE just prior to pt leaving clinic: CV, Lungs, and Neuro exam all WNL. Vitals taken just prior to patient leaving clinic: WNL. Patient stated that she felt much better and ambulated out of the clinic with her father without difficulty.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes abnormal, Blood test, Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain all over, pain at injection site, fatigue, muscle aches, runny nose, stuffy nose, chest congestion, mucus, sinus drainage, all turned into sinus infection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Pain, Paranasal sinus hypersecretion, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Pain all over, pain at injection site, fatigue, muscle aches, runny nose, stuffy nose, chest congestion, mucus, sinus drainage, all turned into sinus infection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Secretion discharge, Sinusitis
Clinical narrative: Pain all over, pain at injection site, fatigue, muscle aches, runny nose, stuffy nose, chest congestion, mucus, sinus drainage, all turned into sinus infection.
Age: 60.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Pain in extremity
Clinical narrative: Called PCP office about 2 weeks after given flu shot to ask if it was normal for my arm to hurt after the shot.  I was told to apply hot packs to my left arm and give it another week.  Did not improve and was sent to PT consultation on Oct 23, 2013 to start and started PT thereafter.
Age: 64.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Aphagia, Erythema, Hyperhidrosis, Local swelling, Pain in extremity
Clinical narrative: Had a fever of 102 and arm swelling to size of fist and it was all red and painful. I could not eat for 6 days and lost 13 pounds in that time and the temp. finally broke on Sat. 11/02/2013.
Age: 64.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Vaccination complication, Weight decreased
Clinical narrative: Had a fever of 102 and arm swelling to size of fist and it was all red and painful. I could not eat for 6 days and lost 13 pounds in that time and the temp. finally broke on Sat. 11/02/2013.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Biopsy, Blister, Blood test, Laboratory test, Lip swelling
Clinical narrative: 06/13/2013 Ulcers and sores in mouth. 07/16 Emergency Room Swollen Lips. Severe Rash all over body. Blister on right hand and Penis. 09/03/2013 Lips swollen sores in mouth Severe Rash. 09/07/2013 Follow up Doctor visit.  09/11 Allergist. 09/28/2013 Reoccurence Severe Rash Blisters in mouth. 10/01/2013 Infectious desease Doctor. 10/02/2013 Dermatologist. 10/19  Reoccurence same syptoms Reoccurence Severe Rash
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Mouth ulceration, Oral mucosal blistering, Rash generalised, Stomatitis
Clinical narrative: 06/13/2013 Ulcers and sores in mouth. 07/16 Emergency Room Swollen Lips. Severe Rash all over body. Blister on right hand and Penis. 09/03/2013 Lips swollen sores in mouth Severe Rash. 09/07/2013 Follow up Doctor visit.  09/11 Allergist. 09/28/2013 Reoccurence Severe Rash Blisters in mouth. 10/01/2013 Infectious desease Doctor. 10/02/2013 Dermatologist. 10/19  Reoccurence same syptoms Reoccurence Severe Rash
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from the consumer's husband refers to a 65 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 16-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot and dose not reported), subcutaneous. There was no concomitant medication. On 16-OCT-2013, the patient developed a small rash at the injection site. The rash was not painful. The patient sought for medical attention (spoke to pharmacist). No lab diagnostics performed. TYLENOL was given as treatment for the event. The outcome of small rash at the injection site was reported as not recovered. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Borrelia test negative, Hypoaesthesia, Hypoaesthesia oral, Mastication disorder
Clinical narrative: Pt presented to ER 2 days after receiving flu shot. Complaining of numbness and tingly feeling on left side of face, lips, tongue. Difficulty chewing on left side. Blood work neg. Lyme titer neg. Patient given prednisone and acyclovir. Symptoms: Acute Bells Palsey.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia oral, VIIth nerve paralysis
Clinical narrative: Pt presented to ER 2 days after receiving flu shot. Complaining of numbness and tingly feeling on left side of face, lips, tongue. Difficulty chewing on left side. Blood work neg. Lyme titer neg. Patient given prednisone and acyclovir. Symptoms: Acute Bells Palsey.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain
Clinical narrative: Pneumovax within 3 hrs of dose pt arm began to swell by 12AM swelling ranged from elbow to shoulder with pain radiating down to waist. Went to ER had prednisone observed 1H swelling reduced then sent home with antibiotic steroid and prednisone.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives developed in genital and inguinal area.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pinching, throbbing pain in shoulder area - left arm.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Pain in (L) arm day of injection, then pain in biceps, the following day, the bulla on (R) biceps area. Tender along upper arm, no erythema/heat/fevers.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Pt states shingles lesion occurred 3 days after vaccine given on (R) ear auricle - It was "painful and lasted for 5 days."
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient called on 10/30/13 and reported that she developed cellulitis at the site of the injection.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus
Clinical narrative: About 45 min after influenza vaccine was given she felt SOB and itchy. O2 Sat. 89-91% of RA. Gave O2. Albuterol nebulizer and SOLUMEDROL IM. Patient was transported to ED by paramedics.
Age: 7.0
Sex: U
Vaccine: HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 7 year old patient (gender unknown). Pertinent medical history and drug reactions/allergies were not reported. On 8-OCT-2013, the patient was vaccinated with RECOMBIVAX HB, 1.0 ml (adult dose), intramuscular. Other suspect therapies included VAQTA 1.0 ml (adult dose). Concomitant therapy was not reported. No adverse effect was reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 6 year old patient (gender unknown). Pertinent medical history and drug reactions/allergies were not reported. On 18-OCT-2013, the patient was vaccinated with RECOMBIVAX HB, 1.0 ml (adult dose), intramuscular. Other suspect therapies included VAQTA 1.0 ml (adult dose). Concomitant therapy was not reported. No adverse effect was reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65 year old patient of unknown gender. On 29-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose, frequency and route not reported) and a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route not reported) at the same office visit. No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple patients of unknown age and gender. It was reported that on unknown dates, multiple unspecified patients may have been administered with an improperly stored RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). RECOMBIVAX HB was exposed to 30 degrees Fahrenheit for 11.5 hours which was not supported. The nurse was unsure if this improperly stored vaccine was administered. No concomitant therapy was reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Fall, Palpitations, Tremor
Clinical narrative: Fell while running; not sure if weak from falling or from vaccine. Next day felt very weak like if it was taking extra effort for muscles/nerves to work. Heart was racing but not continuously. Heart rate at 96 beats/minute which is odd since runner for many years. Felt shaky also. Breathing ok but if took deep breath felt woozy, lightheadedness, dizziness comes and goes. Today feel pretty good. Heart is fast still woozy. Doesn't feel like getting a cold. 11/2 called doctor but did not receive any recommendations.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Inflammation
Clinical narrative: This is a spontaneous report from a contactable physician via sales representative. A patient of unspecified age ethnicity and gender started to received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single. Medical history included myeloma. the patient's concomitant medications were not reported. The patient experienced 4 episodes of inflammatory cellulitis on an unspecified date with outcome of unknown.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5, 6VAX-F, PPV, RV5
Symptoms: Death
Clinical narrative: Death.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Antinuclear antibody negative, Biopsy kidney abnormal, Blood creatinine increased, Cryoglobulins absent, Double stranded DNA antibody
Clinical narrative: Case number PHHY2013US121733, is an initial spontaneous report received from physician (from another manufacturer-Pfizer) on 07 Oct 2013 and 09 Oct 2013 and forwarded by Incyte Corporation (Mfr Control number: 2013IN002346) on 14 Oct 2013. This report refers to a 68-year-old male enrolled in a Pfizer Sponsored Interventional Study. Relevant medical history included primary thrombocytosis complicated by secondary myelofibrosis, stem cell transplant followed by mesenchymal stem cells because of delayed haemopoietic recovery. Relevant adverse events (AEs) during the study included cutaneous graft versus host disease (GVHD) in Nov 2010, which resolved. The patient received JAKAVI tablets for an unspecified indication from an unknown date at an unknown dose. Co-suspect medications included the following intramuscular immunizations: PCV single dose injection intramuscularly on 03 Sep 2010, 12 Oct 2010, 09 Nov 2010 and 16 May 2011, pneumococcal polysaccharide vaccine investigational product (IP) single dose injection on 27 Jun 2011 via intramuscular route, Influenza virus vaccine trivalent single dose on Jan 2012, Tdap single dose in Jan 2012, IPV single dose in Jan 2012 and Hib single dose in Jan 2012. Post-study, on 06 Jul 2012 one year after the last study vaccine with Pneumococcal 23-Valent Polysaccharide, the patient developed nephrotic syndrome and progressive renal failure (creatinine 2.19 mg/dL) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs suggestive of an autoimmune process. Tests included the antinuclear antibody (ANA) titer, anti-dsDNA antibody and cryoglobulins. Serology results for hepatitis B and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. The investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogenic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis is extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. The outcome of the event were not reported. Causality of the event was reported as not suspected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Glomerulonephritis membranoproliferative, Haemodialysis, Hepatitis B test negative, Hepatitis C test negative, Nephrotic syndrome
Clinical narrative: Case number PHHY2013US121733, is an initial spontaneous report received from physician (from another manufacturer-Pfizer) on 07 Oct 2013 and 09 Oct 2013 and forwarded by Incyte Corporation (Mfr Control number: 2013IN002346) on 14 Oct 2013. This report refers to a 68-year-old male enrolled in a Pfizer Sponsored Interventional Study. Relevant medical history included primary thrombocytosis complicated by secondary myelofibrosis, stem cell transplant followed by mesenchymal stem cells because of delayed haemopoietic recovery. Relevant adverse events (AEs) during the study included cutaneous graft versus host disease (GVHD) in Nov 2010, which resolved. The patient received JAKAVI tablets for an unspecified indication from an unknown date at an unknown dose. Co-suspect medications included the following intramuscular immunizations: PCV single dose injection intramuscularly on 03 Sep 2010, 12 Oct 2010, 09 Nov 2010 and 16 May 2011, pneumococcal polysaccharide vaccine investigational product (IP) single dose injection on 27 Jun 2011 via intramuscular route, Influenza virus vaccine trivalent single dose on Jan 2012, Tdap single dose in Jan 2012, IPV single dose in Jan 2012 and Hib single dose in Jan 2012. Post-study, on 06 Jul 2012 one year after the last study vaccine with Pneumococcal 23-Valent Polysaccharide, the patient developed nephrotic syndrome and progressive renal failure (creatinine 2.19 mg/dL) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs suggestive of an autoimmune process. Tests included the antinuclear antibody (ANA) titer, anti-dsDNA antibody and cryoglobulins. Serology results for hepatitis B and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. The investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogenic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis is extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. The outcome of the event were not reported. Causality of the event was reported as not suspected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Renal failure, Toxicity to various agents
Clinical narrative: Case number PHHY2013US121733, is an initial spontaneous report received from physician (from another manufacturer-Pfizer) on 07 Oct 2013 and 09 Oct 2013 and forwarded by Incyte Corporation (Mfr Control number: 2013IN002346) on 14 Oct 2013. This report refers to a 68-year-old male enrolled in a Pfizer Sponsored Interventional Study. Relevant medical history included primary thrombocytosis complicated by secondary myelofibrosis, stem cell transplant followed by mesenchymal stem cells because of delayed haemopoietic recovery. Relevant adverse events (AEs) during the study included cutaneous graft versus host disease (GVHD) in Nov 2010, which resolved. The patient received JAKAVI tablets for an unspecified indication from an unknown date at an unknown dose. Co-suspect medications included the following intramuscular immunizations: PCV single dose injection intramuscularly on 03 Sep 2010, 12 Oct 2010, 09 Nov 2010 and 16 May 2011, pneumococcal polysaccharide vaccine investigational product (IP) single dose injection on 27 Jun 2011 via intramuscular route, Influenza virus vaccine trivalent single dose on Jan 2012, Tdap single dose in Jan 2012, IPV single dose in Jan 2012 and Hib single dose in Jan 2012. Post-study, on 06 Jul 2012 one year after the last study vaccine with Pneumococcal 23-Valent Polysaccharide, the patient developed nephrotic syndrome and progressive renal failure (creatinine 2.19 mg/dL) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs suggestive of an autoimmune process. Tests included the antinuclear antibody (ANA) titer, anti-dsDNA antibody and cryoglobulins. Serology results for hepatitis B and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. The investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogenic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis is extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. The outcome of the event were not reported. Causality of the event was reported as not suspected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Glomerulonephritis membranoproliferative, Hepatitis B test negative, Hepatitis C test negative, Nephrotic syndrome, Renal failure
Clinical narrative: Case number PHHY2013US121733, is an initial spontaneous report received from physician (from another manufacturer-Pfizer) on 07 Oct 2013 and 09 Oct 2013 and forwarded by Incyte Corporation (Mfr Control number: 2013IN002346) on 14 Oct 2013. This report refers to a 68-year-old male enrolled in a Pfizer Sponsored Interventional Study. Relevant medical history included primary thrombocytosis complicated by secondary myelofibrosis, stem cell transplant followed by mesenchymal stem cells because of delayed haemopoietic recovery. Relevant adverse events (AEs) during the study included cutaneous graft versus host disease (GVHD) in Nov 2010, which resolved. The patient received JAKAVI tablets for an unspecified indication from an unknown date at an unknown dose. Co-suspect medications included the following intramuscular immunizations: PCV single dose injection intramuscularly on 03 Sep 2010, 12 Oct 2010, 09 Nov 2010 and 16 May 2011, pneumococcal polysaccharide vaccine investigational product (IP) single dose injection on 27 Jun 2011 via intramuscular route, Influenza virus vaccine trivalent single dose on Jan 2012, Tdap single dose in Jan 2012, IPV single dose in Jan 2012 and Hib single dose in Jan 2012. Post-study, on 06 Jul 2012 one year after the last study vaccine with Pneumococcal 23-Valent Polysaccharide, the patient developed nephrotic syndrome and progressive renal failure (creatinine 2.19 mg/dL) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs suggestive of an autoimmune process. Tests included the antinuclear antibody (ANA) titer, anti-dsDNA antibody and cryoglobulins. Serology results for hepatitis B and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. The investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogenic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis is extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. The outcome of the event were not reported. Causality of the event was reported as not suspected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Serology negative, Toxicity to various agents
Clinical narrative: Case number PHHY2013US121733, is an initial spontaneous report received from physician (from another manufacturer-Pfizer) on 07 Oct 2013 and 09 Oct 2013 and forwarded by Incyte Corporation (Mfr Control number: 2013IN002346) on 14 Oct 2013. This report refers to a 68-year-old male enrolled in a Pfizer Sponsored Interventional Study. Relevant medical history included primary thrombocytosis complicated by secondary myelofibrosis, stem cell transplant followed by mesenchymal stem cells because of delayed haemopoietic recovery. Relevant adverse events (AEs) during the study included cutaneous graft versus host disease (GVHD) in Nov 2010, which resolved. The patient received JAKAVI tablets for an unspecified indication from an unknown date at an unknown dose. Co-suspect medications included the following intramuscular immunizations: PCV single dose injection intramuscularly on 03 Sep 2010, 12 Oct 2010, 09 Nov 2010 and 16 May 2011, pneumococcal polysaccharide vaccine investigational product (IP) single dose injection on 27 Jun 2011 via intramuscular route, Influenza virus vaccine trivalent single dose on Jan 2012, Tdap single dose in Jan 2012, IPV single dose in Jan 2012 and Hib single dose in Jan 2012. Post-study, on 06 Jul 2012 one year after the last study vaccine with Pneumococcal 23-Valent Polysaccharide, the patient developed nephrotic syndrome and progressive renal failure (creatinine 2.19 mg/dL) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs suggestive of an autoimmune process. Tests included the antinuclear antibody (ANA) titer, anti-dsDNA antibody and cryoglobulins. Serology results for hepatitis B and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. The investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogenic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis is extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. The outcome of the event were not reported. Causality of the event was reported as not suspected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Dysgraphia, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a  25 year old female patient with allergy to acetaminophen, PERCOCET, oxycodone. The patient's medical history included had a defibrillator/pacemaker and ventricular tachycardia and genetic defect NC185. On 13-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021346, expiration date 01-OCT-2015, 0.5 ml, intramuscular) and on 15-OCT-2013 she was vaccinated with the second dose of GARDASIL (lot # J009243, expiration date 23-APR-2016, 0.5 ml, intramuscular). Concomitant therapies included aspirin (manufacturer unknown), CARDIZEM, flecainide acetate and ethinyl estradiol, TRI-SPRINTEC. Several hours after receiving the second dose of injection she was experiencing body aches with no fever. She was also having tingling in the arm that received the GARDASIL injection. She had difficulty writing and typing. She took 4 ADVIL tablets and had minimal relief. The patient then told the registered nurse that she had the same symptoms when she received the first dose of GARDASIL. At that time (after the first dose) she went to her family physician (unspecified name) who ordered a Computed Axial Tomography (CAT) scan and other unspecified tests (unspecified dates). All test results came back negative. Her symptoms never went away completely after the first dose. The patient told the nurse her symptoms had now worsened after receiving the second dose of GARDASIL. The patient had not recovered from the events. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Dysgraphia, Laboratory test normal, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a  25 year old female patient with allergy to acetaminophen, PERCOCET, oxycodone. The patient's medical history included had a defibrillator/pacemaker and ventricular tachycardia and genetic defect NC185. On 13-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021346, expiration date 01-OCT-2015, 0.5 ml, intramuscular) and on 15-OCT-2013 she was vaccinated with the second dose of GARDASIL (lot # J009243, expiration date 23-APR-2016, 0.5 ml, intramuscular). Concomitant therapies included aspirin (manufacturer unknown), CARDIZEM, flecainide acetate and ethinyl estradiol, TRI-SPRINTEC. Several hours after receiving the second dose of injection she was experiencing body aches with no fever. She was also having tingling in the arm that received the GARDASIL injection. She had difficulty writing and typing. She took 4 ADVIL tablets and had minimal relief. The patient then told the registered nurse that she had the same symptoms when she received the first dose of GARDASIL. At that time (after the first dose) she went to her family physician (unspecified name) who ordered a Computed Axial Tomography (CAT) scan and other unspecified tests (unspecified dates). All test results came back negative. Her symptoms never went away completely after the first dose. The patient told the nurse her symptoms had now worsened after receiving the second dose of GARDASIL. The patient had not recovered from the events. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report as received from the mother of a 11 month old male patient with allergies to peanuts. On 15-MAY-2000 the patient was vaccinated with the first dose of (Merck) VARIVAX (lot # 631476/1004J, EXP date 10-DEC-2000). On 08-AUG-2008 the patient was vaccinated with the second dose of (Merck) VARIVAX  (lot # reported as 05284 or 0528Y). On an unknown date in 2011 the patient experienced severe reaction to sulfa and was hospitalized. Patient sought unspecified medical attention. There was no lab diagnostics performed. At the time of report, the status of patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Acute hepatic failure, Death
Clinical narrative: This spontaneous report as received from a consumer via a twitter refers to his/her daughter of unknown age. On an unknown date the patient was vaccinated with GARDASIL, reported as "Merck HPV vaccine" (dose, frequency, route, lot# and expiration date unknown). On an unknown date the perfectly healthy patient died 2 weeks after vaccine acute liver failure. The reporter considered the vaccine murdered his/her daughter. Upon internal review, vaccine acute liver failure was considered to be medically significant. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness, Myositis, Pain in extremity, Quality of life decreased
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-Oct-2013) concerns a 33-year-old female patient with no pertinent medical history or allergies. Concomitant medication included tretinoin and unspecified vitamins. On 27-Sep-2013, the patient was vaccinated with intramuscular AFLURIA (batch: R53207) in the left arm, at a dose of 0.5mL. On the same day, after vaccination, the patient developed soreness, loss of range of motion and strength, in her left arm. The patient believed the vaccination may have been injected a little higher than normal. When the symptoms first appeared it caused her significant disability and affected her quality of life. On 09-Oct-2013, the patient saw a healthcare provider and had a shoulder x-ray, which was normal. The healthcare provider stated that the patient had an inflamed muscle in her left arm and prescribed naproxen and daily stretching exercises. The patient reported that her symptoms had gotten better but were not 100 percent.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb normal
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-Oct-2013) concerns a 33-year-old female patient with no pertinent medical history or allergies. Concomitant medication included tretinoin and unspecified vitamins. On 27-Sep-2013, the patient was vaccinated with intramuscular AFLURIA (batch: R53207) in the left arm, at a dose of 0.5mL. On the same day, after vaccination, the patient developed soreness, loss of range of motion and strength, in her left arm. The patient believed the vaccination may have been injected a little higher than normal. When the symptoms first appeared it caused her significant disability and affected her quality of life. On 09-Oct-2013, the patient saw a healthcare provider and had a shoulder x-ray, which was normal. The healthcare provider stated that the patient had an inflamed muscle in her left arm and prescribed naproxen and daily stretching exercises. The patient reported that her symptoms had gotten better but were not 100 percent.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Diarrhoea, Heart rate increased, Pallor
Clinical narrative: Diarrhea, sudden weakness, paleness and elevated heart rate.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Pyrexia, Ultrasound abdomen
Clinical narrative: Severe rt quadrant abdominal pain with fever 99.9 lasting 5 days abdominal ultrasound no results as of 11/05/2013.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Muscle spasms, Musculoskeletal disorder, Pain in extremity, Sensation of heaviness
Clinical narrative: Internal swollen arm, the whole arm, pain in the whole arm from the shoulder down to the hand, when cold hurts more either if its outside of inside a place, the pain is feels like muscle spasms, arm feels heavy like its going to fall, can't use it. Pain increases as the days go by.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left shoulder very sore and has not gone away after a close to a month.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Computerised tomogram normal, Nuclear magnetic resonance imaging brain normal, VIIth nerve paralysis
Clinical narrative: This spontaneous consumer report (initial receipt 24-Oct-2013) concerns a 64 year old male patient with a medical history of diabetes. Concomitant medications included atenolol, fluoxetine, gabapentin, simvastatin and metformin. The patient had no drug reactions/allergies. On an unspecified date 4 weeks ago, the patient received AFLURIA (batch unspecified). After receiving AFLURIA, the patient developed Bell's Palsy. The patient sought medical attention through seeing his physician. CAT (computerised axial tomography) scan and MRI (magnetic resonance imaging) were negative for brain damage. No treatment was given for the adverse event. The event outcome was not recovered.