chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: C-reactive protein normal, Carbon dioxide normal, Cellulitis, Differential white blood cell count, Eosinophil count normal
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Eosinophil percentage increased, Fatigue, Feeling hot, Glomerular filtration rate, Haematocrit normal
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Haemoglobin normal, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Joint swelling, Lymph node pain, Lymphadenopathy, Lymphocyte count normal, Lymphocyte percentage increased
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Metabolic function test
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Monocyte count normal, Monocyte percentage, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Neck pain, Neutrophil count decreased, Neutrophil percentage decreased, Nodule, Pain in extremity
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Papule, Platelet count normal, Poor quality sleep, Protein total normal, Rash
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Rash pruritic, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal, Rheumatoid arthritis
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Rheumatoid factor negative, Rhinorrhoea, Scab, Skin hyperpigmentation, Somnolence
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site warmth, White blood cell count
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 1.85
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blister, Injection site erythema, Injection site swelling
Clinical narrative: Started red welps on rt/left thighs afternoon on day of injections, worse on next day. 3/25/13 3-4 bullae, swelling extending most of bilateral thighs.
Age: 74.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Local swelling and redness distal to injection site (R) arm (deltoid). Fever up to 102 about 24 hours after injection. Anorexia w/o N/V/D.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old patient of unknown gender. On 20-MAR-2013 the patient was vaccinated with ZOSTAVAX (19400 PFU) lot # 0240AE (expiry date 15-MAR-2013), 0.65 ml, subcutaneous. Dose number was not reported. On 20-MAR-2013 the patient was administered an expired dose of ZOSTAVAX. No adverse effects were reported. The patient did not seek for medical attention. Additional information is requested.
Age: 1.83
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Macular papular rash on entire body except palms & soles. Began 3/20/13.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Asthenia, Blood glucose increased, Pancreatic disorder, Pollakiuria, Thirst
Clinical narrative: Patient was showing signs of weakness, vomiting, extremely thirsty, using bathroom a lot, after taking her to doctor her blood sugar was well over 600 therfore causing her to be sent straight to hospital where she wad diagnosed with pancreatic failure and is now insulin dependant.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Type 1 diabetes mellitus, Vomiting
Clinical narrative: Patient was showing signs of weakness, vomiting, extremely thirsty, using bathroom a lot, after taking her to doctor her blood sugar was well over 600 therfore causing her to be sent straight to hospital where she wad diagnosed with pancreatic failure and is now insulin dependant.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Oropharyngeal pain, Pain
Clinical narrative: Tiredness, sleeping all the time, body pain, fever, runny nose, site throat, loss of appetite.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Tiredness, sleeping all the time, body pain, fever, runny nose, site throat, loss of appetite.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Localised oedema, Pyrexia, Soft tissue infection
Clinical narrative: Pt developed local erythema and edema, + fever after receiving influenza and pneumococcal vaccine in upper left arm.  Originally rec'd diphenhydramine for hypersensitivity rxn, however symptoms did not improve, eventually treated for soft tissue infection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: 3-4 RED SPOTS APPROX HALF DOLLAR SIZE, WARM TO TOUCH.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Expired drug administered
Clinical narrative: Medical Assistant noticed the HPV vaccine was expired after the vaccine was administered. MD, Supervisor and Health Dept were notified.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Erythema, Local swelling, Periorbital oedema, Psychomotor hyperactivity
Clinical narrative: Pt developed edema and erythema around R eye and anterior lower neck. She was reported to be "acting hyper ten times her usual self" at dinner at home. Seen in clinic at 6:30pm that evening. Was calm and cooperative but had swelling as reported. Received Benadryl x 1. Was monitored x 30 mins with improvement of erythema and edema.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haematoma, Head discomfort, Laboratory test normal, Musculoskeletal stiffness, Pain
Clinical narrative: Patient reported on 3/18/13. 48 hours after shot: heavy/stiff feeling at the base of the skull and throbbing jaw pain. Symptoms subsided after 3-4 weeks, but returned and has persisted through present. Large hematoma on arm x 3-4 weeks. No fever.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in jaw
Clinical narrative: Patient reported on 3/18/13. 48 hours after shot: heavy/stiff feeling at the base of the skull and throbbing jaw pain. Symptoms subsided after 3-4 weeks, but returned and has persisted through present. Large hematoma on arm x 3-4 weeks. No fever.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haematoma, Laboratory test normal, Musculoskeletal stiffness, Pain in jaw, Sensation of heaviness
Clinical narrative: Patient reported on 3/18/13. 48 hours after shot: heavy/stiff feeling at the base of the skull and throbbing jaw pain. Symptoms subsided after 3-4 weeks, but returned and has persisted through present. Large hematoma on arm x 3-4 weeks. No fever.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Autism
Clinical narrative: This spontaneous report as received form a registered nurse refers to a 8 year old female patient. On an unknown date the patient was vaccinated with hepatitis b vaccine shortly after birth (manufacturer unspecified). The patient then on an unknown date received 2 doses of RECOMBIVAX HB (5mcg/0.5 ml) (lot #, expiration date and route not reported) at appropriate intervals. On an unknown date the patient developed autism. The outcome of autism was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Her arm became sore, red and very swollen near site of injection. The redness and swelling went away after 24 hours and soreness after 48 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Papule, Varicella
Clinical narrative: Broke out in papules scattered on torso, back and arms..seen in office dx with atypical varicella.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Immunized arm swollen from elbow to hand, painful, loss of sleep.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Headache, Pallor, Pyrexia, Rash papular, Skin lesion
Clinical narrative: PT RECEIVED YF ON 3/21/13 AROUND 1400 AND LATER THAT EVENING PT NOTICED HIVES; HEADACHE & FEVER ONSET WAS ON 3/22/13.  HIVES HAVE PERSISTED SINCE THURSDAY BUT HEADACHE & FEVER SUBSIDED ON 3/23/13.  "Scattered small pink skin lesions on lateral abdominal wall, left greater than right.  Lesions scattered raised blanching mildly erythematous papules consistent with localized hives on the left & right lateral upper abdominal and lower to mid chest wall."
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: PT RECEIVED YF ON 3/21/13 AROUND 1400 AND LATER THAT EVENING PT NOTICED HIVES; HEADACHE & FEVER ONSET WAS ON 3/22/13.  HIVES HAVE PERSISTED SINCE THURSDAY BUT HEADACHE & FEVER SUBSIDED ON 3/23/13.  "Scattered small pink skin lesions on lateral abdominal wall, left greater than right.  Lesions scattered raised blanching mildly erythematous papules consistent with localized hives on the left & right lateral upper abdominal and lower to mid chest wall."
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Body pruritis, redness, swelling at injection site. Received Depo-Medrol.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Bacterial test, Chlamydia test, HIV antibody, Rash vesicular, Vaccination complication
Clinical narrative: 22 y/o male was complaining of spreading vesicular lesions involving his hands, face, neck, abdominal, back, and genital areas. Lesions originated on hands about 14 days after initial smallpox vaccination. Pt stated no h/o eczema. Pt was referred to disease management for further analysis the next day and was diagnosed with vaccinia from vaccination. Pt denied and any flu-like symptoms or painful urination. He was prescribed Benadryl, Zyrtec, and was placed on 7 day quarters. Pt was instructed to f/u with infectious disease or PCM post 1 week.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccinia virus infection
Clinical narrative: 22 y/o male was complaining of spreading vesicular lesions involving his hands, face, neck, abdominal, back, and genital areas. Lesions originated on hands about 14 days after initial smallpox vaccination. Pt stated no h/o eczema. Pt was referred to disease management for further analysis the next day and was diagnosed with vaccinia from vaccination. Pt denied and any flu-like symptoms or painful urination. He was prescribed Benadryl, Zyrtec, and was placed on 7 day quarters. Pt was instructed to f/u with infectious disease or PCM post 1 week.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Confusional state, Dizziness, Dyspnoea
Clinical narrative: Very confused, out of it, brain wasn't working, couldn't think, pain of injection site, eyes swollen, very bad headache, very dizzy, nausea 7 AM - trouble breathing, very difficult to breathe, very dizzy, very confused, brain fuzzy/not working right, shortness of breath, leg aching, bad stomach ache, body hurt.  That lasted all day and into the next day.  Very, very worried and scared patient!!  Doctor on call said to take Zyrtec and 2 Benadryl and see if that helped.  Patient was very sleepy but still had symptoms... got a bit better, then worse with confusion.  Very confused at times.  Still on 3-25 - still confused and brain not clear.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Fear, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Very confused, out of it, brain wasn't working, couldn't think, pain of injection site, eyes swollen, very bad headache, very dizzy, nausea 7 AM - trouble breathing, very difficult to breathe, very dizzy, very confused, brain fuzzy/not working right, shortness of breath, leg aching, bad stomach ache, body hurt.  That lasted all day and into the next day.  Very, very worried and scared patient!!  Doctor on call said to take Zyrtec and 2 Benadryl and see if that helped.  Patient was very sleepy but still had symptoms... got a bit better, then worse with confusion.  Very confused at times.  Still on 3-25 - still confused and brain not clear.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Mental impairment, Nausea, Pain, Pain in extremity, Somnolence
Clinical narrative: Very confused, out of it, brain wasn't working, couldn't think, pain of injection site, eyes swollen, very bad headache, very dizzy, nausea 7 AM - trouble breathing, very difficult to breathe, very dizzy, very confused, brain fuzzy/not working right, shortness of breath, leg aching, bad stomach ache, body hurt.  That lasted all day and into the next day.  Very, very worried and scared patient!!  Doctor on call said to take Zyrtec and 2 Benadryl and see if that helped.  Patient was very sleepy but still had symptoms... got a bit better, then worse with confusion.  Very confused at times.  Still on 3-25 - still confused and brain not clear.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fibromyalgia, Insomnia, Migraine
Clinical narrative: Migranes, insomnia, fibromyalgia.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Abdominal distension, Choking sensation, Computerised tomogram abdomen abnormal, Death, Dyspnoea
Clinical narrative: He started having high grade fever on 3/12, reaching up to 102.9.  I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin.  He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck.  He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support.  He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond.  He had upper GI bleed and subsequent CT scan showed free air in the abdomen.  He underwent emergency surgery that showed gastric gangrene and perforation.  Total gastrectomy was performed.  He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Ear infection, Gastrectomy, Gastric perforation, Gastrointestinal gangrene, General physical health deterioration
Clinical narrative: He started having high grade fever on 3/12, reaching up to 102.9.  I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin.  He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck.  He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support.  He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond.  He had upper GI bleed and subsequent CT scan showed free air in the abdomen.  He underwent emergency surgery that showed gastric gangrene and perforation.  Total gastrectomy was performed.  He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Guillain-Barre syndrome, Haemodialysis, Mechanical ventilation, Plasmapheresis, Post procedural complication
Clinical narrative: He started having high grade fever on 3/12, reaching up to 102.9.  I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin.  He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck.  He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support.  He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond.  He had upper GI bleed and subsequent CT scan showed free air in the abdomen.  He underwent emergency surgery that showed gastric gangrene and perforation.  Total gastrectomy was performed.  He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Pyrexia, Renal failure, Respiratory failure, Surgery, Upper gastrointestinal haemorrhage
Clinical narrative: He started having high grade fever on 3/12, reaching up to 102.9.  I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin.  He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck.  He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support.  He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond.  He had upper GI bleed and subsequent CT scan showed free air in the abdomen.  He underwent emergency surgery that showed gastric gangrene and perforation.  Total gastrectomy was performed.  He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Arthralgia, Asthenia, Death, Ear pain, Headache
Clinical narrative: He started having high grade fever on 3/12, reaching up to 102.9.  I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin.  He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck.  He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support.  He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond.  He had upper GI bleed and subsequent CT scan showed free air in the abdomen.  He underwent emergency surgery that showed gastric gangrene and perforation.  Total gastrectomy was performed.  He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: He started having high grade fever on 3/12, reaching up to 102.9.  I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin.  He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck.  He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support.  He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond.  He had upper GI bleed and subsequent CT scan showed free air in the abdomen.  He underwent emergency surgery that showed gastric gangrene and perforation.  Total gastrectomy was performed.  He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Body temperature increased, Erythema, Induration, Skin warm, Swelling
Clinical narrative: Dark red circle with swelling the size of a nickel, red ring around it the size of a half dollar. Hot to touch, swollen, hard lump the width of a golf ball underneath the skin still there. Low grade temperature even with alternating Tylenol and ibuprofen.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Audiogram abnormal, Herpes zoster, Nuclear magnetic resonance imaging normal, Sudden hearing loss, Ultrasound scan normal
Clinical narrative: Sudden loss of hearing (history of Bell's palsy) followed by shingles rash outbreak after prednisone was stopped.  Occurred on 3/10/2013.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Joint stiffness
Clinical narrative: Extreme fatigue, body aches, MS like symptoms, muscle pain, headaches, dizziness, continued illness.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Multiple sclerosis, Myalgia, Neurological symptom, Pain, Vaccination complication
Clinical narrative: Extreme fatigue, body aches, MS like symptoms, muscle pain, headaches, dizziness, continued illness.
Age: 30.0
Sex: F
Vaccine: FLU3, HEPA, PPV
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Left arm localized redness, induration at injection site of Influenza and pneumococcal vaccines. Fever started < 24 hours after injection. Treat with antibiotics for 10 days (KEFLEX).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Left arm injection site reaction/rash about 5 in x 5 in.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed systemic chickenpox 24hrs after vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat and swelling at vaccine site left deltoid without pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Brief generalized seizure. No treatment given. 2 days after vaccine administered patient has hx of febrile seizures on 2 other occasions. This seizure fever was less than 38 degrees C.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Brief generalized seizure. No treatment given. 2 days after vaccine administered patient has hx of febrile seizures on 2 other occasions. This seizure fever was less than 38 degrees C.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt saw NP at clinic on March 15th regarding the redness around the injection site. Pt reported no fever or signs of malaise, however the injection site remained sore & swollen for 3 days post vaccination. Pt was given KEFLEX 500mg Q6h x 7 days by the clinic.
Age: 5.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Oral herpes, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant and the patient's mother refers to a 5 year old female patient. On 14-MAR-2013 the patient was accidentally vaccinated with a dose of GARDASIL (lot # H013831, exp 06-MAR-2015) in error. The medical assistant stated that the patient was supposed to receive a dose of DTaP. On the evening of 18-MAR-2013, the patient was observed to have an elevated temperature and fever blister on her mouth (also reported as lip). The patient was seen by the physician, who prescribed ZOVIRAX four times a day and TYLENOL for the patient's fever. At the time of reporting, the patient's outcome was unknown. Action taken and the causality of events and GARDASIL were not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 12 year old female patient with no drug reactions/allergies. Current condition included amblyopia of left eye. The patient's medical history including respiratory syncytial virus (rsv) as an infant. On 25-JUL-2012 the patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot # 671994/1537AA, expiration date 21-JUN-2014) intramuscularly in the left arm. Concomitant therapies included DIFLUCAN. On 25-JUL-2012, the patient experienced pain of her left arm when she received GARDASIL. She also developed an itchy rash on her abdomen within 2 hours of receiving GARDASIL. She took BENADRYL but the rash continued to spread and reached toward her mid-lower back. She was prescribed prednisone. No laboratory diagnostic studies were performed. The patient also started taking DIFLUCAN on 25-JUL-2012 (same date as she received vaccine). The reporter thought events were related to GARDASIL. Patient sought medical attention by office visits. The patient had not received any further doses of GARDASIL. The outcome of the events were reports as recovered/resolved on an unspecified date. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. On 16-MAR the patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # H019035, expiry date 17-JAN-2014). No other co-suspects products were reported. No concomitant medications were reported. On 17-MAR-2013, the patient experienced redness, swelling, itchy, and around the injection site it was sore. The patient had sought medical attention via calling pharmacy. The patient was not given the treatment for the adverse events. There were no laboratory diagnostics studies performed. The outcome of redness, swelling, itchy, and around the injection site it was sore was reported as recovering/resolving. The pharmacist wanted a lot check. This is one of several reports from the same source. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 84 year old male patient. The patient received a dose of ZOSTAVAX (lot# not reported) about 5-6 years ago, in approximately March 2007. Concomitant therapies included PROTONIX and aspirin. The patient came down with shingles "recently". The patient contacted office on 07-MAR-2013 for pain and rash he was experiencing and he went to Emergency Room (ER) on 09-MAR-2013 with complaints of rash on his waist and groin and pain. Hospital name and location unspecified. The patient was diagnosed with shingles in Emergency Room (ER) and was prescribed acetaminophen, VICODIN and gabapentin but he was not admitted to hospital. Patient came into office for follow up visit on 18-MAR-2013 and physician reported that patient's rash was dried up by then but patient was still experiencing pain. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an immunization official (also reported as health care worker) refers to an unspecified number of patients (demographics unspecified). The patient might have received doses of GARDASIL (lot number, expiry date unspecified) and LIQUID PEDVAXHIB (lot number, expiry date unspecified) that were exposed to unknown temperatures from 01-NOV-2012 to 15-NOV-2012. Immunization official reports that the practice had no vaccine temperature storage records for the time period in question; it could not be determined if a vaccine temperature storage excursion actually occurred. No adverse effect reported. The outcome was unknown. It was unspecified if the patients had sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients. On unknown dates the patients were vaccinated with improperly stored M-M-R II (dose and lot # not reported). No adverse effects reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several report received from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients. On unknown dates the patients was vaccinated with improperly stored GARDASIL (dose and lot # not reported). No adverse effects reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer refers to her 22 year-old son (patient) with no pertinent medical history and drug reactions/allergies. On 31-DEC-2012, the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported) in the arm. After his first dose, his arm hurt. On 16-MAR-2013 the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route) in the arm. His arm hurt even worse and went numb. The arm hurt him all day. He did not know if he would get a third dose. The consumer stated that the vial of medication was not shaken before administration. The patient was vaccinated in the pharmacy. No treatment was rendered for the events. No laboratory tests were performed. The events did not resolve at the time of this report. Causality was not reported. Consumer also stated another son, age 19 years, receives dose 1 GARDASIL (lot#, expiration date and route not reported) on an unknown date in August 2012 and he did not get his second dose of GARDASIL (lot#, expiration date and route not reported) until an unknown date in December 2012. He had no adverse reactions. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (dose and lot # not reported). No adverse effects reported. The patient was also vaccinated with improperly stored GARDASIL (MARRS # 1303USA011920) and M-M-R II (MARRS # 1303USA011921). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a consumer refers to his daughter, a 12 year old female patient. In November 2012 the patient was vaccinated with the first dose of GARDASIL (lot # not reported). The patient's arm (left or right not specified) became swollen on the evening after the injection. The symptoms eventually subsided. (Timeframe not specified). The second dose of GARDASIL (lot # not reported) was administered (time not specified) and the patient's arm became swollen again. The patient did not seek medical attention. No treatment was given. The reporter (Father) stated the patient had fully recovered. Additional information is not expected.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Electromyogram normal, Lumbar puncture normal, Muscular weakness, Paraesthesia
Clinical narrative: Numbness, tingling in legs, progressed to be associated with weakness and drop in nerve conduction velocities.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Lumbar puncture normal, Muscular weakness, Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: Numbness, tingling in legs, progressed to be associated with weakness and drop in nerve conduction velocities.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: The flu shot was mis-administered. It was injected into the joint of my shoulder, above the muscle. I immediately felt a "funny" feeling in my fingers like when one hits their "funny bone". For the next few days my arm would naturally want to curl into a kind of palsy position, curling inward to relieve the discomfort. EXTREME pain in joint when extending my arm straight and outward, sometimes a burning sensation that extends throughout my whole arm and almost constantly discomfort in my fingers. Now the joint is starting to "click" and "pop" when I move it in certain ways. My shoulder has been injured due to the shot being injected into the joint. I am VERY concerned about permanent loss of mobility and constant pain, burning, discomfort.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Burning sensation, Drug administered at inappropriate site, Immediate post-injection reaction, Joint crepitation
Clinical narrative: The flu shot was mis-administered. It was injected into the joint of my shoulder, above the muscle. I immediately felt a "funny" feeling in my fingers like when one hits their "funny bone". For the next few days my arm would naturally want to curl into a kind of palsy position, curling inward to relieve the discomfort. EXTREME pain in joint when extending my arm straight and outward, sometimes a burning sensation that extends throughout my whole arm and almost constantly discomfort in my fingers. Now the joint is starting to "click" and "pop" when I move it in certain ways. My shoulder has been injured due to the shot being injected into the joint. I am VERY concerned about permanent loss of mobility and constant pain, burning, discomfort.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Joint injury, Musculoskeletal discomfort, Pain, Sensory disturbance
Clinical narrative: The flu shot was mis-administered. It was injected into the joint of my shoulder, above the muscle. I immediately felt a "funny" feeling in my fingers like when one hits their "funny bone". For the next few days my arm would naturally want to curl into a kind of palsy position, curling inward to relieve the discomfort. EXTREME pain in joint when extending my arm straight and outward, sometimes a burning sensation that extends throughout my whole arm and almost constantly discomfort in my fingers. Now the joint is starting to "click" and "pop" when I move it in certain ways. My shoulder has been injured due to the shot being injected into the joint. I am VERY concerned about permanent loss of mobility and constant pain, burning, discomfort.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site rash, Rash
Clinical narrative: Onset of rash around SPV site and chest, face and upper legs.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 3x5 cm area erythema (L) posterior arm. Firmness at the site et heat/warm. Applied heat to site x 15min et provided TYLENOL extra strength (1000mg).
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a male patient od unknown age. On 01-MAR-2013 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot no reported as 1537aa, exp 21-JUN-2014). It was reported that the patient may have received a GARDASIL dose that had previously been exposed to -4 for 24 hours and -2c for six days. The reporter was unsure if the patient received the GARDASIL due to discrepancies in their documentation, but it was stated that no adverse events were documented. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 19-MAR-2013, the patient was vaccinated with a dose of MMR II (lot number and expiry date reported as H009784 and 15-MAY-2013 respectively, dose unspecified), subcutaneously that was exposed to a temperature excursion that was not supported (50 degrees Fahrenheit (F) for 12.5 hours). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacy student via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). Approximately one week after receiving ZOSTAVAX the patient was diagnosed with shingles. Treatment information and laboratory diagnostic tests performed were unspecified by the reported. Outcome of the event was unknown. Causality was not reported. The pharmacist was not aware of this event and believed that this may have occurred at a different unspecified pharmacy where the pharmacy student may have been an intern prior to her rotation at this pharmacy. This report is linked to the case 1303USA012322 (patient : wife) due to patient-partner link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an immunization official (also reported as health care worker) refers 6 patients (demographics unspecified). Between 01-NOV-2012 to 15-NOV-2012, the patients received MMR II (lot number, expiry date, dose, route, site unspecified) that were exposed to unknown temperatures. The MMR II were exposed to unknown temperatures from 01-NOV-2012 to 15-NOV-2012. Immunization official reported that the practice had no vaccine temperature storage records for the time period in question; it could not be determined if a vaccine temperature storage excursion actually occurred. No adverse effect reported. The outcome was unknown. It was unspecified if the patients had sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, subdermal. Dose number, dose and lot number were not reported. On an unknown date the patient experienced unspecified allergic reaction to GARDASIL. The outcome of unspecified allergic reaction was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her child, a patient of unknown age and gender with no reported medical history. On 04-SEP-2007 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 1. On 04-NOV-2007 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 2. On 20-FEB-2008 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 3. No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced first dose given on 09-04-2007, second dose on 11/04/2007 and third dose 2/20/2008 (Inappropriate schedule of vaccine administered). Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a doctor of pharmacy concerning his approximately 52 year old mother with no pertinent medical history and no drug reaction or allergies. On 19-May-2011 (also reported as back in 2011), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On an unknown date in August 2012, the patient experienced shingles episode. The patient sought an unspecified medical attention. The patient was treated with VALTREX. No lab tests were performed. The outcome of shingles episode was unknown. The relatedness for shingles episode was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an immunization official (also reported as health care worker) refers 7 patients (demographics unspecified). Between 01-NOV-2012 to 15-NOV-2012, the patients might have received VARIVAX (Merck) (lot number, expiry date, dose, route, site unspecified) that were exposed to unknown temperatures. The VARIVAX (Merck) were exposed to unknown temperatures from 01-NOV-2012 to 15-NOV-2012. Immunization official reported that the practice had no vaccine temperature storage records for the time period in question; it could not be determined if a vaccine temperature storage excursion actually occurred. No adverse effect reported. The outcome was unknown. It was unspecified if the patients had sought medical attention. All telephone attempts to obtain follow-up information has been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody test
Clinical narrative: This spontaneous report was received from a certified medical assistant (also reported as healthcare worker) refers to a female patient of unknown age with no pertinent medical history and drug reactions/allergies. On an unknown date the patient was vaccinated with MMR II (lot #, expiration date and route not reported). Concomitant medications included birth control pills (unspecified). The patient had received unknown number of doses of MMR II on an unspecified date. On an unknown date the patient experienced equivocal titer results for rubella. The event did not resolve at the time of this report. The patient sought an unspecified medical attention. Causality was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacy student via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). Approximately one week after receiving ZOSTAVAX the patient was diagnosed with shingles. Treatment information and laboratory diagnostic tests performed were unspecified by the reported. Outcome of the event was unknown. Causality was not reported. The pharmacy was not aware of this event and believed that this may have occurred at a different unspecified pharmacy where the pharmacy student may have been an intern prior to her rotation at this pharmacy. This report is linked to the case 1303USA011966 (patient : husband) due to patient-partner link. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Guillain-Barre syndrome, Headache, Hypoaesthesia oral, Hypokinesia
Clinical narrative: Lower back pain, headaches, numb lips, leg pain, leg, no leg movement, hospitalized with GBS.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Lower back pain, headaches, numb lips, leg pain, leg, no leg movement, hospitalized with GBS.
Age: 0.9
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash vesicular, Secondary transmission, Skin lesion
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning his 11 month old nephew (male). On 19-MAY-2011, the grandmother of the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). On an unknown date, approximately in February 2013 (about a month ago), the patient experienced whole body rash of unknown origin and he was hospitalized on an unknown date for about 5-6 days. A lot of testings (unspecified) were done and thought that rash could be related to HSV1 (herpes simplex virus 1). He was prescribed acyclovir and rash completely resolved on an unknown date. Approximately on 14-MAR-2013 (a week ago), the patient experienced lesion of rash on his thumb. The pharmacist described current rash for his nephew as blistering rash. Pharmacist did not known if rash of his nephew was ever diagnosed as chickenpox rash. The outcome of lesion of rash on his thumb was unknown. The pharmacist suspected the possibility of secondary transmission from vaccine virus from ZOSTAVAX that his mother received or from shingles breakout that his mother had. The reporter considered the events whole body rash and blistering rash could be related to ZOSTAVAX. Varicella Zoster Virus Identification Program (VZVIP) packet faxed. This one of the two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Appendicectomy, Appendicitis, Computerised tomogram abdomen, Full blood count
Clinical narrative: Appendicitis 3/16 - appendectomy.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Got what appeared to be a blister type reaction with large area of redness around injection site. Had pictures on her phone. Advised to see PCP before we would give second dose. May have been a hive around injection.