chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Father of child woke to child jerking, unresponsive, didn't respond to father's attempts to wake - shaking continued < 1 min., child was then limp, incontinent of stool, urine. Child taken immediately to ED. Child awoke approx. 1-1 1/2 min after dad awoke to shaking but did not return to normal for approx 2 min.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Blood urea normal, Carbon dioxide normal, Computerised tomogram head normal, Dyskinesia, Faecal incontinence
Clinical narrative: Father of child woke to child jerking, unresponsive, didn't respond to father's attempts to wake - shaking continued < 1 min., child was then limp, incontinent of stool, urine. Child taken immediately to ED. Child awoke approx. 1-1 1/2 min after dad awoke to shaking but did not return to normal for approx 2 min.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Haematocrit normal, Haemoglobin normal, Hypotonia, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Father of child woke to child jerking, unresponsive, didn't respond to father's attempts to wake - shaking continued < 1 min., child was then limp, incontinent of stool, urine. Child taken immediately to ED. Child awoke approx. 1-1 1/2 min after dad awoke to shaking but did not return to normal for approx 2 min.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Platelet count normal, Tremor, Unresponsive to stimuli, Urinary incontinence, Urine analysis normal
Clinical narrative: Father of child woke to child jerking, unresponsive, didn't respond to father's attempts to wake - shaking continued < 1 min., child was then limp, incontinent of stool, urine. Child taken immediately to ED. Child awoke approx. 1-1 1/2 min after dad awoke to shaking but did not return to normal for approx 2 min.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count normal
Clinical narrative: Father of child woke to child jerking, unresponsive, didn't respond to father's attempts to wake - shaking continued < 1 min., child was then limp, incontinent of stool, urine. Child taken immediately to ED. Child awoke approx. 1-1 1/2 min after dad awoke to shaking but did not return to normal for approx 2 min.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Angiogram retina abnormal, Angiotensin converting enzyme decreased, Blindness, Blood electrolytes normal, C-reactive protein increased
Clinical narrative: Information has been received from the physician in a literature report. This case report refers to a 20-year-old female patient. The patient's concurrent condition included myopia (spherical equivalent: -4) and there was no history of headache, systemic or ocular disease, or ocular trauma; no neurological, auditory, or skin changes were evident. A recent pregnancy test result had been negative. On an unknown date, the patient was vaccinated with second dose of GARDASIL (dose, frequency and route were unspecified) and was vaccinated with first dose 7 months previously. On an unknown date, the patient presented with acute-onset blurred vision bilaterally 3 weeks after her second injection of GARDASIL. Best-corrected visual acuity (BCVA) was 20/60 in both eyes. Aqueous flare was noted with occasional inflammatory cells in the anterior chamber and vitreous. There were no keratic precipitates. The patient had bilateral diffuse neurosensory retinal detachments at the posterior poles with yellowish subretinal exudation at the fovea, Fluorescein angiography revealed bilateral disc leakage, with staining of a peripheral retinal vessel in the left eye. Late pooling of fluorescein within the exudative retinal detachments was noted, and it was unclear whether any diffuse leakage at the level of the RPE contributed to sequestration of subretinal fluid, midperipheral yellowish choroidal lesions, seen on color photography, correlated spatially with foci of hypofluorescence during the mid-phase of the angiogram, Spectral-domain optical coherence tomography (SD-OCT) with enhanced-depth imaging confirmed the presence of multiple elevations of the neurosensory retina with intervening areas of persistent retinal attachment; the subretinal fluid exhibited a degree of hyper-reflectivity, the choroid was thickened at the posterior pole, especially below the fovea, beyond the depth range of the OCT device, subfoveal choroidal thickness measured by ultrasound exceeded 1,000 um, laboratory findings revealed a raised erythrocyte sedimentation rate (29 mm/h) and positive HLA-DRB1 *0405 haplotype (Table), chest X-ray findings were normal. The patient was started on oral prednisolone 60 mg daily for 2 weeks, followed by a tapering regimen leading to discontinuation at 6 weeks due to rapid improvement. One month after presentation, the anterior uveitis and exudative retinal detachments had resolved and visual acuity improved to 20/25 bilaterally, during follow-up, choroidal thickness reduced to 400 um at 1 month and 300 um at 3 months, at 5 months, choroidal thickness had stabilized at 300 um, with BCVA of 20/20 and 20/25 in the right and left eyes, respectively. The outcome of bilateral acute visual loss was recovering (reported as improved). The reporter considered the events to be related to GARDASIL. The events were considered to be medically significant (serious). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Full blood count normal, HLA marker study positive, Iridocyclitis, Liver function test normal
Clinical narrative: Information has been received from the physician in a literature report. This case report refers to a 20-year-old female patient. The patient's concurrent condition included myopia (spherical equivalent: -4) and there was no history of headache, systemic or ocular disease, or ocular trauma; no neurological, auditory, or skin changes were evident. A recent pregnancy test result had been negative. On an unknown date, the patient was vaccinated with second dose of GARDASIL (dose, frequency and route were unspecified) and was vaccinated with first dose 7 months previously. On an unknown date, the patient presented with acute-onset blurred vision bilaterally 3 weeks after her second injection of GARDASIL. Best-corrected visual acuity (BCVA) was 20/60 in both eyes. Aqueous flare was noted with occasional inflammatory cells in the anterior chamber and vitreous. There were no keratic precipitates. The patient had bilateral diffuse neurosensory retinal detachments at the posterior poles with yellowish subretinal exudation at the fovea, Fluorescein angiography revealed bilateral disc leakage, with staining of a peripheral retinal vessel in the left eye. Late pooling of fluorescein within the exudative retinal detachments was noted, and it was unclear whether any diffuse leakage at the level of the RPE contributed to sequestration of subretinal fluid, midperipheral yellowish choroidal lesions, seen on color photography, correlated spatially with foci of hypofluorescence during the mid-phase of the angiogram, Spectral-domain optical coherence tomography (SD-OCT) with enhanced-depth imaging confirmed the presence of multiple elevations of the neurosensory retina with intervening areas of persistent retinal attachment; the subretinal fluid exhibited a degree of hyper-reflectivity, the choroid was thickened at the posterior pole, especially below the fovea, beyond the depth range of the OCT device, subfoveal choroidal thickness measured by ultrasound exceeded 1,000 um, laboratory findings revealed a raised erythrocyte sedimentation rate (29 mm/h) and positive HLA-DRB1 *0405 haplotype (Table), chest X-ray findings were normal. The patient was started on oral prednisolone 60 mg daily for 2 weeks, followed by a tapering regimen leading to discontinuation at 6 weeks due to rapid improvement. One month after presentation, the anterior uveitis and exudative retinal detachments had resolved and visual acuity improved to 20/25 bilaterally, during follow-up, choroidal thickness reduced to 400 um at 1 month and 300 um at 3 months, at 5 months, choroidal thickness had stabilized at 300 um, with BCVA of 20/20 and 20/25 in the right and left eyes, respectively. The outcome of bilateral acute visual loss was recovering (reported as improved). The reporter considered the events to be related to GARDASIL. The events were considered to be medically significant (serious). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Optical coherence tomography abnormal, Red blood cell sedimentation rate increased, Retinal detachment, Treponema test negative, Tuberculin test negative
Clinical narrative: Information has been received from the physician in a literature report. This case report refers to a 20-year-old female patient. The patient's concurrent condition included myopia (spherical equivalent: -4) and there was no history of headache, systemic or ocular disease, or ocular trauma; no neurological, auditory, or skin changes were evident. A recent pregnancy test result had been negative. On an unknown date, the patient was vaccinated with second dose of GARDASIL (dose, frequency and route were unspecified) and was vaccinated with first dose 7 months previously. On an unknown date, the patient presented with acute-onset blurred vision bilaterally 3 weeks after her second injection of GARDASIL. Best-corrected visual acuity (BCVA) was 20/60 in both eyes. Aqueous flare was noted with occasional inflammatory cells in the anterior chamber and vitreous. There were no keratic precipitates. The patient had bilateral diffuse neurosensory retinal detachments at the posterior poles with yellowish subretinal exudation at the fovea, Fluorescein angiography revealed bilateral disc leakage, with staining of a peripheral retinal vessel in the left eye. Late pooling of fluorescein within the exudative retinal detachments was noted, and it was unclear whether any diffuse leakage at the level of the RPE contributed to sequestration of subretinal fluid, midperipheral yellowish choroidal lesions, seen on color photography, correlated spatially with foci of hypofluorescence during the mid-phase of the angiogram, Spectral-domain optical coherence tomography (SD-OCT) with enhanced-depth imaging confirmed the presence of multiple elevations of the neurosensory retina with intervening areas of persistent retinal attachment; the subretinal fluid exhibited a degree of hyper-reflectivity, the choroid was thickened at the posterior pole, especially below the fovea, beyond the depth range of the OCT device, subfoveal choroidal thickness measured by ultrasound exceeded 1,000 um, laboratory findings revealed a raised erythrocyte sedimentation rate (29 mm/h) and positive HLA-DRB1 *0405 haplotype (Table), chest X-ray findings were normal. The patient was started on oral prednisolone 60 mg daily for 2 weeks, followed by a tapering regimen leading to discontinuation at 6 weeks due to rapid improvement. One month after presentation, the anterior uveitis and exudative retinal detachments had resolved and visual acuity improved to 20/25 bilaterally, during follow-up, choroidal thickness reduced to 400 um at 1 month and 300 um at 3 months, at 5 months, choroidal thickness had stabilized at 300 um, with BCVA of 20/20 and 20/25 in the right and left eyes, respectively. The outcome of bilateral acute visual loss was recovering (reported as improved). The reporter considered the events to be related to GARDASIL. The events were considered to be medically significant (serious). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound eye abnormal, Vision blurred, Visual acuity reduced, Visual acuity tests abnormal
Clinical narrative: Information has been received from the physician in a literature report. This case report refers to a 20-year-old female patient. The patient's concurrent condition included myopia (spherical equivalent: -4) and there was no history of headache, systemic or ocular disease, or ocular trauma; no neurological, auditory, or skin changes were evident. A recent pregnancy test result had been negative. On an unknown date, the patient was vaccinated with second dose of GARDASIL (dose, frequency and route were unspecified) and was vaccinated with first dose 7 months previously. On an unknown date, the patient presented with acute-onset blurred vision bilaterally 3 weeks after her second injection of GARDASIL. Best-corrected visual acuity (BCVA) was 20/60 in both eyes. Aqueous flare was noted with occasional inflammatory cells in the anterior chamber and vitreous. There were no keratic precipitates. The patient had bilateral diffuse neurosensory retinal detachments at the posterior poles with yellowish subretinal exudation at the fovea, Fluorescein angiography revealed bilateral disc leakage, with staining of a peripheral retinal vessel in the left eye. Late pooling of fluorescein within the exudative retinal detachments was noted, and it was unclear whether any diffuse leakage at the level of the RPE contributed to sequestration of subretinal fluid, midperipheral yellowish choroidal lesions, seen on color photography, correlated spatially with foci of hypofluorescence during the mid-phase of the angiogram, Spectral-domain optical coherence tomography (SD-OCT) with enhanced-depth imaging confirmed the presence of multiple elevations of the neurosensory retina with intervening areas of persistent retinal attachment; the subretinal fluid exhibited a degree of hyper-reflectivity, the choroid was thickened at the posterior pole, especially below the fovea, beyond the depth range of the OCT device, subfoveal choroidal thickness measured by ultrasound exceeded 1,000 um, laboratory findings revealed a raised erythrocyte sedimentation rate (29 mm/h) and positive HLA-DRB1 *0405 haplotype (Table), chest X-ray findings were normal. The patient was started on oral prednisolone 60 mg daily for 2 weeks, followed by a tapering regimen leading to discontinuation at 6 weeks due to rapid improvement. One month after presentation, the anterior uveitis and exudative retinal detachments had resolved and visual acuity improved to 20/25 bilaterally, during follow-up, choroidal thickness reduced to 400 um at 1 month and 300 um at 3 months, at 5 months, choroidal thickness had stabilized at 300 um, with BCVA of 20/20 and 20/25 in the right and left eyes, respectively. The outcome of bilateral acute visual loss was recovering (reported as improved). The reporter considered the events to be related to GARDASIL. The events were considered to be medically significant (serious). Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: None stated.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Loss of consciousness, Paraesthesia
Clinical narrative: Patient had tingling sensations all over the body. Also pain in the back of her head. Per patient's family members she passed out for about 5 seconds. EMS was called and patient's vital signs were all ok. Patient refused to go to hospital with EMS.
Sex: M
Vaccine: TTOX
Symptoms: Apparent death, Muscle spasms
Clinical narrative: Initial unsolicited case received from a consumer on 27-Oct-2015. This case involves a male patient (age not reported) who had vaccinated with a dose of Tetanus Toxoid (Manufacturer: unknown, batch number, dose number, route and site of administration were not reported) on unspecified date about twenty five years ago. Medical history and concomitant medications were not reported. Illness at time of vaccination was reported that patient had stepped on a rusty nail. On unspecified date, after vaccination the patient's muscles seized up and he nearly died. It was reported that physician advised him to never receive another tetanus shot and hence patient looked for a pertussis vaccine only. Laboratory examinations and corrective treatments were not reported. At the time of this report, patient was recovered from the event and had provided very little information. Documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Deafness, Herpes zoster oticus, Laboratory test, VIIth nerve paralysis
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to a 19 year old female patient. No medical history and concurrent conditions of the patient were reported. On 07-JUN-2001, the patient was vaccinated with VARIVAX (Merck) of dose 0.5 ml, subcutaneously (lot number: 16004 and expiry date: not reported). No concomitant medications were reported. It was reported that the patient received the completed doses of VARIVAX (Merck). On an unknown date, at the age of 19, patient developed a form of shingles and was diagnosed with Ramsay Hunt Syndrome. The patient had experienced hearing loss and facial paralysis. On an unknown date, unspecified laboratory tests were performed and results were not provided. The patient was given unspecified treatment for the adverse events on an unknown date. It was reported that the patient healed from facial paralysis and was still suffering from hearing loss. The outcome of Ramsay Hunt Syndrome was unknown. The causality of Ramsay Hunt Syndrome, facial paralysis and hearing loss was not reported. No product quality complaint (PQC) was filed. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Swollen arm. Red and inflamed arm.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 14 cm x 14 cm area on upper left thigh, tender to touch, warm and erythema. Treated with ibuprofen and BENADRYL and ice.
Age: 33.0
Sex: F
Vaccine: FLUR3
Symptoms: Cellulitis, Erythema, Local swelling, Pain
Clinical narrative: Vaccine done at (Emp. Health) due to an egg allergy. Normal soreness day of vaccine however the following evening soreness increased to pain with swelling (65-70mm) and redness. Reported next day to Infection Prevention seen by her and referred to Emp Health. They Dx cellulitis and Rx clindamycin 300 mg 3xday x 10 days.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Lip swelling
Clinical narrative: At 5:30pm when awakened from sleep, parent noticed swelling of upper lip. Mom concerned might be reaction to FLUMIST took child to local urgent care. Doctor noted minimal swelling. No other issues noted by attending phys. BENADRYL given. Dr does not suspect anaphylaxis.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt said her arm hurt and she couldn't raise it. She applied heating pad.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pruritus generalised, Vaccination site swelling
Clinical narrative: Patient said that the evening of 11/6/15, she started feeling itchy all over. Her arm where the vaccine was received was reddish pink, swelled up, and was itchy. She took Benadryl and the swelling went down. As of Monday, 11/9/15, the arm is better and she is not as itchy as on Friday evening.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Massive swelling of arm, hot to touch and red. ED staff diagnosed as Cellulitis and prescribed cephalexin. Continued to get worse and fear of cutting off circulation in hand due to severe swelling. Return visit to ED on 11/1/15 and then follow up with Physician on 11/2/15.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient awoke with soreness at injection site which developed into erythema and swelling.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received flu shot 10/10/15. She called the pharmacy 10/27/15 and stated that her arm is still hurting, she can barely move her arm and the shot was given up high on the arm, near the shoulder area. Her arm did not hurt before the shot. She has not been to the doctor and has never had a previous similar issue with vaccinations.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain, soreness at injection site, 2 weeks post vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Vaccine administered on Tues. Patient called Thurs. indicating she went to an urgent care center and was told she has cellulitis. she was going to PCP on Fri.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Night sweats, Pyrexia
Clinical narrative: Stiff neck, headache, fever, night sweats.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Received shot 13 days ago. Still experiencing shoulder muscle pain. Talked to doctor, they suggested Ibuprofen and warm compress. Family physician at facility.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient received a Flu shot FLUZONE HD and a PREVNAR-13 shot on 10-25-15. Both shots were administered in the left arm due to physical therapy/soreness in the right arm. Patient has had no reaction in the past to Flu shots. She stated that when she awoke today (10/31/15) her arm was bright red and very itchy. She came to the pharmacy to show me and she had a large erythematous area where the shots were given about 5 inches by 2.5 inches oval with warmth. Advised BENADRYL at bedtime.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Confusional state, Dysarthria, Lethargy
Clinical narrative: Confusion, lethargy, inability to walk (severe weakness bilaterally), low grade fever 98.8 (normal is 97.0), slurred speech. All symptoms resolved within 24 hours without treatment.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Confusion, lethargy, inability to walk (severe weakness bilaterally), low grade fever 98.8 (normal is 97.0), slurred speech. All symptoms resolved within 24 hours without treatment.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Severe body aches starting day after getting PREVNAR 13 and lasting until given Rx of Prednisone on 10/28/15.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560 expiry date 15-JUN-2017, lot # L013429 expiry date 21-JUL-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Pt received FLUMIST and MENACTRA on 10/12/15 and started with headache that night, followed by runny nose, sore throat, cough and fever up to 102 in the next day, with symptoms persisting for 5 days, slow but complete resolution of symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site swelling
Clinical narrative: Mild swelling of both thighs (left greater than right) at injection site.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Headache, Injection site erythema, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Sore arm, redness at site of injection, warm to touch, neck stiffness, chills, headache.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity
Clinical narrative: Sore arm, redness at site of injection, warm to touch, neck stiffness, chills, headache.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Vaccine administered 10/14/15. Patient admitted to hospital, on 10/17/15 - 10/20/15. Diagnosed with Guillain-Barre. Patient admitted to hospital 10/21/15 - 10/23/15 for side effects of treatment medications.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Persistent left shoulder pain since receiving the Flu injection. No pain at time of injection.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Headache, Nuclear magnetic resonance imaging brain normal, Seizure
Clinical narrative: 24 hrs after receiving the High-Dose flu shot, pt complained of a severe headache. He had 3 seizures in the next 5 hrs. Pt seen in ER x2 and remained in hosp 48 hrs.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Patient experienced severe tachycardia 4 hrs receiving the flu shot. Was in the ER.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Pain, Skin exfoliation, Skin reaction, Vaccination complication
Clinical narrative: Got Flu shot 5 days ago. Now have cellulitis vs reaction. Localized skin reaction w/sloughing pain. Seen 10/15: reaction is resolving.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Pt. reported severe bruising and pain after immunization.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine on Wednesday 28 Oct 15 at 10:12 A.M. and stated that his left arm started swelling at the injection site that after noon. Came to clinic this morning 30 Oct 15 att 8:40 A.M. with swelling and redness of left arm from injection site to elbow, warm to touch.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TD
Symptoms: Face and mouth X-ray, Headache
Clinical narrative: Given vaccinations and 24 hrs later developed a Headache and shifted - symptoms have improved.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid area swollen with erythema 3 cm x 3 cm patch with warmth.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Wife told pharmacy on 10/29/15 that husband had a reaction as conveyed by tech to me. I tried to directly receive a statement on 10/30 when I was notified, but the patient did not answer the phone.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Injection site rash, Nausea, Rash
Clinical narrative: Fast heartbeat; Nausea; Felt faint. Rash at injection site and on chest, back, arms on 10/28/15.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Aggression, Computerised tomogram head normal, Confusional state, Crying, Generalised tonic-clonic seizure
Clinical narrative: Pt received Tdap, Flu and HPV shots. Immediately after 3rd shot (HPV) pt c/o not feeling well, then had approx 10 seconds of tonic-clonic seizure activity, and became unresponsive. She woke up about 30 sec. later, confused and mildly combative. She was diaphoretic, c/o bad headache. B/P 160/94 P 88 O2 sat 84%. O2 applied, drank water, v/s improved: 129/84 P 66 O2 sat 99%. Pt c/o hands tingling, pounding H/A weepy and confused. Sent to ER.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Headache, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Malaise
Clinical narrative: Pt received Tdap, Flu and HPV shots. Immediately after 3rd shot (HPV) pt c/o not feeling well, then had approx 10 seconds of tonic-clonic seizure activity, and became unresponsive. She woke up about 30 sec. later, confused and mildly combative. She was diaphoretic, c/o bad headache. B/P 160/94 P 88 O2 sat 84%. O2 applied, drank water, v/s improved: 129/84 P 66 O2 sat 99%. Pt c/o hands tingling, pounding H/A weepy and confused. Sent to ER.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Paraesthesia, Unresponsive to stimuli
Clinical narrative: Pt received Tdap, Flu and HPV shots. Immediately after 3rd shot (HPV) pt c/o not feeling well, then had approx 10 seconds of tonic-clonic seizure activity, and became unresponsive. She woke up about 30 sec. later, confused and mildly combative. She was diaphoretic, c/o bad headache. B/P 160/94 P 88 O2 sat 84%. O2 applied, drank water, v/s improved: 129/84 P 66 O2 sat 99%. Pt c/o hands tingling, pounding H/A weepy and confused. Sent to ER.
Age: 1.61
Sex: F
Vaccine: DTAP, FLU3, HEPA, PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Influenza like illness, Muscular weakness
Clinical narrative: Started on 11/5/15 left arm weakness with throbbing. Denies loss of ROM, denies tingling and numbness in fingers. No redness or swelling at injection site. Did not seek medical care for. Also had flu-like symptoms start on this date too of diarrhea, nausea, stomach cramps, vertigo, headache. Encourage to see PCP or walk in clinic if weakness in arm persists. Told to use warm pack and ice as needed take TYLENOL or ibuprofen if needed. Avoid laying on (L) arm.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain, Vertigo
Clinical narrative: Started on 11/5/15 left arm weakness with throbbing. Denies loss of ROM, denies tingling and numbness in fingers. No redness or swelling at injection site. Did not seek medical care for. Also had flu-like symptoms start on this date too of diarrhea, nausea, stomach cramps, vertigo, headache. Encourage to see PCP or walk in clinic if weakness in arm persists. Told to use warm pack and ice as needed take TYLENOL or ibuprofen if needed. Avoid laying on (L) arm.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Contusion, Dizziness, Fall
Clinical narrative: Approx 7 P - chills, shivers, pain in muscles, walking difficult. Extreme dizziness, nausea, vomiting, very weak. Fell injuring (L) arm (bruising) dizziness continued all day. 10-18 AM - 10-19 slight dizziness. Stayed in bed most of day.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Limb injury, Myalgia, Nausea, Vomiting
Clinical narrative: Approx 7 P - chills, shivers, pain in muscles, walking difficult. Extreme dizziness, nausea, vomiting, very weak. Fell injuring (L) arm (bruising) dizziness continued all day. 10-18 AM - 10-19 slight dizziness. Stayed in bed most of day.
Sex: F
Vaccine: FLUR3
Symptoms: Injection site pain
Clinical narrative: This is an initial report of an Adverse Event, received on 15Sep2015, for Protein Sciences FLUBLOK. The female subject, received FLUBLOK Intramuscular on an unknown date. On 15Sep2015, the subject called to report pain on site injection. At the time of the report, the outcome of the event was not reported. Concomitant medications were not reported. The company's assessment of the causal relationship between pain on site injection and FLUBLOK is a possible relationship in light of the safety profile information injection site pain is an expected event. In summary, this case report does not change the known safety profile of FLUBLOK.
Age: 1.69
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dysstasia, Injected limb mobility decreased, Pain
Clinical narrative: Patient given PENTACEL in right upper thigh - within 24 hours he was unable to use his leg to stand or crawl for 7 days - given an absence of any other symptoms except local pain and lameness no treatment was Rx. Recovery complete after 7 days.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: 10/27/15 FLUVIRIN MDV deltoid IM. 10/28/15 Elbow hurts when straightens arm, stretches fingers. PCP: NSAIDs and follow up in 3 days if not improved.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip disorder, Rash, Urticaria
Clinical narrative: Pt developed rash and hives from ZOSTAVAX injection. Also had heaviness of lips within 20 minutes of injection.
Age: 55.0
Sex: F
Vaccine: MNQ, PPV, TD
Symptoms: Arthralgia, Back pain, Burning sensation, Groin pain, Haematology test normal
Clinical narrative: Received 3 vaccinations on 10/12/15 (PNEUMOVAX 23, MENVEO, TENIVAC) - for clinical trial. C/O fever, redness right thigh beginning 10-14-15 lasting approx 2 days. Developed pain (Rt.) lower back, (Rt.) hip on 10-17-15 and went to hospital emergency room. Also with burning sensation in her right leg, pain in her (Rt) groin area. Given pain meds. (Rt.) hip pain and burning sensation (Rt.) leg worsened 10-29-15. Patient seen in office and Rx'd LYRICA.
Age: 55.0
Sex: F
Vaccine: MNQ, PPV, TD
Symptoms: Injection site erythema, Metabolic function test normal, Pyrexia, Urine analysis normal
Clinical narrative: Received 3 vaccinations on 10/12/15 (PNEUMOVAX 23, MENVEO, TENIVAC) - for clinical trial. C/O fever, redness right thigh beginning 10-14-15 lasting approx 2 days. Developed pain (Rt.) lower back, (Rt.) hip on 10-17-15 and went to hospital emergency room. Also with burning sensation in her right leg, pain in her (Rt) groin area. Given pain meds. (Rt.) hip pain and burning sensation (Rt.) leg worsened 10-29-15. Patient seen in office and Rx'd LYRICA.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Local reaction to Influenza vaccine. One round, warm, indurated, blotchy, erythematous, lesion (about 5cm x 5cm) on outer (R) thigh. No tenderness to palpation. No red streaks. Pt on BACTRIM R/o cellulitis.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Rash macular, Skin lesion
Clinical narrative: Local reaction to Influenza vaccine. One round, warm, indurated, blotchy, erythematous, lesion (about 5cm x 5cm) on outer (R) thigh. No tenderness to palpation. No red streaks. Pt on BACTRIM R/o cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hypersensitivity, Pyrexia, Urticaria
Clinical narrative: Next day - overwhelming fatigue. 2nd day - full body hives and chills and fever.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 had been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 14 years old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 11-AUG-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pruritus, Lip swelling
Clinical narrative: Mild itching at Flushot site; swelling in lips, went to physician, given steroid and antihistamines. Now symptoms are gone.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, X-ray limb
Clinical narrative: Shoulder pain began soon after injection, persisting. Emailed correspond with personal physician 10/11, 10/12, 10/19,10/21, 10/26, 10/27, 10/28, 10/29. X Ray 10/28. Orthopedic exam 11/03 diagnosed as bursitis. Pain continuing. Physical therapy commencing next week.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Chronic throat clearing, Cough
Clinical narrative: Constant clearing of throat and continuous coughing; at 8:30 pm used rescue inhaler, didn't help, breathing and coughing became much worse, increase in blood pressure, went to Hospital, Emergency Room.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Respiration abnormal, X-ray
Clinical narrative: Constant clearing of throat and continuous coughing; at 8:30 pm used rescue inhaler, didn't help, breathing and coughing became much worse, increase in blood pressure, went to Hospital, Emergency Room.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Neck pain, Pain
Clinical narrative: Patient is (still as of 11/9/15) having severe pain in her left side.  This pain radiates from her neck to her arm.  Pain relievers do not help. Ice is the only thing that reduces the pain.  Seems to be a muscle problem.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising
Clinical narrative: Pt called pharmacy on 11/8/15 to report bruising around injection site. Bruising started 3 inches down from left shoulder bone and is 2 inches in diameter. Pt reports taking NSAIDs and aspirin daily.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Urticaria
Clinical narrative: Hives all over body including some that formed raised welts or blisters.  Treated with topical steroids.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: Severe pain in arm, decreased ROM, occurring immediately after receiving the injection.
Age: 52.0
Sex: U
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Bursitis, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site reaction
Clinical narrative: I received flu shot unusually high on left shoulder, after injection my arm was "heavy" feeling. The next week to 10 days very sore with limited use of arm. Went to Dr., then again 4 wks later because couldn't use arm, pain, limited motion, trouble dressing and sleeping from pain.
Age: 52.0
Sex: U
Vaccine: FLUX
Symptoms: Limb discomfort, Pain in extremity, Sleep disorder
Clinical narrative: I received flu shot unusually high on left shoulder, after injection my arm was "heavy" feeling. The next week to 10 days very sore with limited use of arm. Went to Dr., then again 4 wks later because couldn't use arm, pain, limited motion, trouble dressing and sleeping from pain.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 had been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 12 month old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 18-SEP-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dysphagia, Headache, Injection site bruising
Clinical narrative: Injection site black bruise 1 1/2" x 1 1/2" upper Rt arm. Still obvious 10 days later. Shot given 10/26/15. By 28th I had chills, headache, mild fever (1 degree) difficulty swallowing, coughing, sneezing, running nose. Today - 5 Nov. I still sniffling and coughing up phlegm.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Injection site black bruise 1 1/2" x 1 1/2" upper Rt arm. Still obvious 10 days later. Shot given 10/26/15. By 28th I had chills, headache, mild fever (1 degree) difficulty swallowing, coughing, sneezing, running nose. Today - 5 Nov. I still sniffling and coughing up phlegm.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Bursitis, Influenza like illness, Joint swelling, Musculoskeletal pain
Clinical narrative: Patient went to provider with swelling and pain in her shoulder, and flu-like symptoms. Provider diagnosed her with bursitis.
Age: 1.05
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 had been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 12 month old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 28-SEP-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Local reaction, Pyrexia
Clinical narrative: Local reaction with cellulitis, fever.
Age: 81.0
Sex: U
Vaccine: FLU3
Symptoms: Amputation stump pain, Phantom pain
Clinical narrative: Severe painful movements in my stump - Had to pack it in ice for (3) three days.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately 2015, reported as on multiple unspecified dates ranging from 15-OCT-2015 to 06-NOV-2015, the patients were vaccinated orally with improperly stored doses of ROTATEQ solution (lot# L008996, expiry date 01-DEC-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest discomfort, Dyspnoea, Lip swelling, Malaise, Urticaria
Clinical narrative: Patient came to our office for flu clinic administered and supplied by CNS (Certified Nursing Company) on Saturday Nov 7th at 1pm. At 1:30 pm patient complained of not feeling well. She had hives all over, swollen lips. c/o tightness in chest and "hard to breath". BENADRYL was given and pt went to ER. She improved quickly w/BENADRYL.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Large bruise at injection site, red inflamed spot progressing down arm toward elbow hot to touch - dx cellulitis by MD pt reports starting day after in came to pharm. clindamycin 150 every 8 hours for 7 days after.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Cough, Erythema, Pain in extremity, Rhinorrhoea
Clinical narrative: Large bruise at injection site, red inflamed spot progressing down arm toward elbow hot to touch - dx cellulitis by MD pt reports starting day after in came to pharm. clindamycin 150 every 8 hours for 7 days after.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Sneezing
Clinical narrative: Large bruise at injection site, red inflamed spot progressing down arm toward elbow hot to touch - dx cellulitis by MD pt reports starting day after in came to pharm. clindamycin 150 every 8 hours for 7 days after.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately 2015, reported as on multiple unspecified dates ranging from 15-OCT-2015 to 06-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# L011846, expiry date 16-JUN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. In approximately 2015, reported as on multiple unspecified dates ranging from 15-OCT-2015 to 06-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL injection (lot # K006191, expiry date 02-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not reported. On an unknown date, the patients were administered improperly stored doses of ROTATEQ (lot# K020181 expiry date 24-JUN-2016, lot# L004466 expiry date 02-AUG-2016, lot# L008054 expiry date 30-NOV-2016; orally, dose not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008053 with exp. 30-NOV-2016, (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.