chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 48 year old female patient. The patient had no pertinent medical history or drug allergies/reactions. On 29-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, lot# K007262, expiry date unspecified, dose and route were not provided) in the arm. Concomitant medications were not provided. "The next day", on 30-OCT-2014, the patient experienced fever, nausea, vomiting, soreness and swelling at the injection site. The pharmacist reported that "3 days after" administration, on 01-NOV-2014, the injection arm "got red hot to the touch" and was very inflamed therefore the patient was taken to a hospital and admitted due to myositis of the injection arm and leukocytosis (unspecified white blood cell count (WBC) levels, onset date unspecified, in approximately 2014). The pharmacist reported that the patient was treated with an unspecified intravenous (I. V.) antibiotic and was released on an unspecified date (in approximately November 2014). The pharmacist required lot check for PNEUMOVAX 23 (lot# K007262, expiry date unspecified) to determine if myositis had occurred with other patients who had received doses from this lot#. The outcome of the events was reported as recovering. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Nausea, Retching
Clinical narrative: Pt became chilled, shaky, dry heaves, dizzy, weak 2 hours after hi dose flu shot - no fever - nauseous in bed all day Saturday 11/8. Sun 11/9 felt better. Took Zofran for nausea.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Pt became chilled, shaky, dry heaves, dizzy, weak 2 hours after hi dose flu shot - no fever - nauseous in bed all day Saturday 11/8. Sun 11/9 felt better. Took Zofran for nausea.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Burning sensation, Nasal congestion, Rhinorrhoea, Sinus headache
Clinical narrative: Complaint of sinuses "on fire" pressure, stuffiness, running nose.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Myalgia, Presyncope
Clinical narrative: Received injection at 0700. Headache began at 1200, severe by 3 pm. Chills started at 3 pm, by 9 pm were rigors. Also experienced presyncope and severe generalized joint and muscle pain. No treatment sought. On following day all symptoms resolved.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Tx: MEDROL dose pack. Sharp pain on left arm where injection was gven along w/numbness down to hand and difficult grip at times.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash on hands and swollen lymph nodes.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Temp to 105.9 one day post vaccine. Temp to 103.6 two days post vaccine. Temp to 100.2 four days post vaccine. Low grade fever five days post. No fever 6 days post.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident
Clinical narrative: CVA 4 hrs post vaccine
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Flushing
Clinical narrative: C/O feeling flushed, chest heaviness, BP 158/100. Patient went to urgent care for medical evaluation.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling, Thirst
Clinical narrative: Patient had immediate severe swelling that kept progressing around injection site. Patient then stated was very thristy. Site progressed to about size of an egg. 911 was called. Patient released by 911 personnel.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Lip oedema, Oedema mouth
Clinical narrative: Lips and ora edema. Lt arm rash at around injection site with redness.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Rash
Clinical narrative: Joint aches, rash on pts trunk. Symptoms came on pt the night after receiving shot that day. Tx: 80 mg deopmedrol IM.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Injection site erythema, Injection site mass, Injection site rash, Injection site swelling
Clinical narrative: Lump at injection site, red hot, swollen rash approx 6 inches x 3 inches, hard spots in the muscles aching, itchy for 3 days. Lump at site still there after a week and a half. Rash lessened over the week.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Myalgia, Pruritus
Clinical narrative: Lump at injection site, red hot, swollen rash approx 6 inches x 3 inches, hard spots in the muscles aching, itchy for 3 days. Lump at site still there after a week and a half. Rash lessened over the week.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling of left arm from shoulder to 2 inches above elbow-hot, burning and feels like skin is going to "pop". Red, itches and rash just below injection site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Severe swelling of left arm from shoulder to 2 inches above elbow-hot, burning and feels like skin is going to "pop". Red, itches and rash just below injection site.
Age: 68.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site reaction, Muscle rigidity, Muscle tightness
Clinical narrative: Patient reported tension across the entire back in deltoid and trap muscles about 5 days post injection. Noted rigidity moved to right should area after seeing Chiropractor.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Autoimmune thrombocytopenia, Epistaxis, Petechiae, Platelet count decreased
Clinical narrative: ITP (Immune Thrombocytopenia Purpura) developed - petechial rash noted, brought to clinic, had nosebleed, platelet count 4000. Started on steroids, platelet count 11,000 on 10/31/14.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Rec'd injection - upper (L) arm at 12:45 pm on 10/20/14. Awoke on 10/21 at 2:00 am w/ severe redness and itching on back of both legs from ankle to knee and front of left leg from ankle upward toward knee extending at 4". 2:45 am took one 10 mg Loratadine and itching subsided within a half-hour. I called nurse healthline at 3:30 am and spoke to an RN. She said I did the right thing and she suggested applying a cold, wet washcloth to legs to relieve itching. I did this and redness and itching went away by 4:00 A.M. and immediately thereafter a large red circle - approx 4" in diameter on outside of and immediately above right knee. I applied cold wet rag to the area and itching went away after 15 minutes. All itching sites were bright red but cool to the touch. I did not feel as if I ever had any fever. On 10/21/at 11:30 pm (R) leg red and itching ankle to knee on outside and middle of leg and (R) side of left knee. Used cold wet rag to relieve itching. (Note: could not take loratadine as one can only take 1 pill within a 24 hr. period). Wed. 10/22 6:30 A.M. red and itching (R) leg from ankle to 1/2 way up inside of calf. Took 10 mg loratadine and used wet washcloth on leg. Itching subsided within approx 1/2 hr. Thurs 10/23 awoke just after midnight. Experienced severe redness, itching, and stinging on left leg outside from ankle to 1/2 way up calf. Big red circle - at 4" diameter. (Too soon to take loratadine). Used cold wet cloth and applied aloe vera gel. Itching gone by 1:00 A.M.). 10/23 (cont'd) 10:00 pm. Redness and itching and stinging from (R) ankle upward about 4" on front of leg and (R) side of ankle. 10:35 pm took 10mg Loratadine and redness, itching and stinging disappeared by 11:00 pm. No problems on 10/24, 25, 26, 27, 28.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: Joint pain 8 hours after administration - took 400 mg Ibuprofen "knocked edge off", swollen lymphnode above right clavical day 2 - to present (day 10). Joint pain stopped Monday (Day 6).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Myalgia, Palpitations
Clinical narrative: About 1 hour after immunizatiion, pt states she felt her heart moving and her throat felt "scratchy"; by the end of the day she felt worse and noted her L upper arm to be swollen and warm with myalgia. No fever. Did not seek care until 11-3-14. Symptoms are better.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: About 1 hour after immunizatiion, pt states she felt her heart moving and her throat felt "scratchy"; by the end of the day she felt worse and noted her L upper arm to be swollen and warm with myalgia. No fever. Did not seek care until 11-3-14. Symptoms are better.
Age: 49.0
Sex: M
Vaccine: FLUC3
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: Muscle weakness, worse in legs, diff. walking up stairs, weak in arms.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Haemorrhage, Syncope
Clinical narrative: Patient fainted approx 15-20 minutes after administration. Patient stated he has not eaten much and felt faint after seeing a small amount of blood on arm after administration.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Pain, tingling, numbness, from my hand to upper arm at the area shot, nervous, restless, weakness of my whole hand/arm.
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Paraesthesia, Restlessness
Clinical narrative: Pain, tingling, numbness, from my hand to upper arm at the area shot, nervous, restless, weakness of my whole hand/arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient felt faint after shot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin warm
Clinical narrative: Around 2 days after receiving Fluzone HD the patient noticed a large bruise covering the width of her arm and as long as her hand. It felt warm for a few days. On 11/1/14 it ws no longer, ot, didn't hurt, and the bruise was changing colors and going away.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Urgent care told pt shot given to high in bursa. Pt had extreme deep pain.
Age: 36.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Loss of strength, numbness, loss of motion. Began with pain. Pt then started complaining of inability to lift arm over head and lift self out of chair.
Age: 36.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Loss of strength, numbness, loss of motion. Began with pain. Pt then started complaining of inability to lift arm over head and lift self out of chair.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe (L) arm, shoulder, neck pain 2 days following injection. No redness or swelling present. Decreased ROM (L) am rt pain. No fever, chills, malaise.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Burning sensation, Erythema, Injection site erythema, Injection site urticaria
Clinical narrative: Pt c/o severe red, raised blister like hives all over body starting with right upper arm. Pt c/o burning and pain from rash x 2 weeks when seen in office 10/24/14.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles, Pain, Rash, Urticaria
Clinical narrative: Pt c/o severe red, raised blister like hives all over body starting with right upper arm. Pt c/o burning and pain from rash x 2 weeks when seen in office 10/24/14.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Received flu vaccine at approx 2 pm on 10/10/14. Vaccine was injected very high almost on shoulder of my left arm. Injection itself was very painful. Within 30 minutes of the injection I had pain going down the arm up the arm into my neck and across my left upper chest from the shoulder. Was unable to lift my arm Friday night (10/10/14). Two and a half weeks later. Still having severe shoulder and arm pain.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Received flu vaccine at approx 2 pm on 10/10/14. Vaccine was injected very high almost on shoulder of my left arm. Injection itself was very painful. Within 30 minutes of the injection I had pain going down the arm up the arm into my neck and across my left upper chest from the shoulder. Was unable to lift my arm Friday night (10/10/14). Two and a half weeks later. Still having severe shoulder and arm pain.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None noted.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Seen by PCP: Swollen, red injection site.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Hives - BENADRYL.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Cough, Influenza virus test negative, Oropharyngeal pain, Streptococcus test negative
Clinical narrative: Received Flu Mist 10/24/14. On Thursday 10/28/14, developed sore throat, cough and stomach update persisted and een on 11/3/14.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Pain, Pyrexia, Sleep terror
Clinical narrative: Night terrors x 2 days, 3-4 a night 11/8, 11/9. Fever, body aches 11/6-7.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm below the deltoid (injection site) began to swell, turn red, and felt warm to the touch. Patient went to primary care MD on 11/7/14 for a DECADRON IM.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Fell unconscious.
Age: 18.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Student began c/o tingling to face, finger weakness to lower extremities. Went to Emergency room - FLUMIST and HPV given at about 10AM on 11/6/2014. Symptoms started about 5:30PM.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Eyelid function disorder, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: On October 13th he awoke with left facial numbness, drooping of his left cheek, asymmetric smile, and inability to close his left eye. He denied paralysis or numbness elsewhere. He also denied trauma, change in his headache pattern, worsening of his blood pressure or glucose level prior to the onset. He denied lesions or pain around his left ear. In the ER, stroke evaluation was negative. Stroke risk factors include HTN, DM, and Hyperlipidemia. Bell's was diagnosed. He was started on 7 days of prednisone which he completed on the 20th.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Nausea, Pain, Tachycardia
Clinical narrative: Pt. recv'd vax on 11/5/14 and then developed nausea, trouble breathing and tachycardia. Had reported a lot of aches and pains too. Pt. took BENADRYL and TYLENOL and eventually Kw/in 24 hrs. symptoms resolved.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Complaints of muscle weakness in left arm.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Heart rate increased, Pain, Urticaria
Clinical narrative: Hives, achiness, accelerated heart rate.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Injection site induration
Clinical narrative: A 2" x 2" induration immediately developed at injection site. Mild bruising immediately which became more extensive over the next 1-2 days.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Rash/spots/hives on upper torso.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza A virus test negative, Lethargy, Myalgia, Pyrexia
Clinical narrative: Muscle pain, lethargy, weakness progressing to fever above 100 degrees F after 3 days - patient went to ER tested negative for flu.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Laboratory test abnormal, Wrong technique in drug usage process
Clinical narrative: Vaccinating pharmacist failed to swab/clean injection site on arm prior to administration of flu vaccine. Patient experienced redness and swelling at injection site 1 and 1/2 days later. Diagnosed with cellulitis and required treatment with antibiotic (levofloxacin 500mg daily for 7 days). Recovering as of 11/7/14 at 7:30 PM.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: Sore arm, pain, flu-like symptoms.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient states she experienced pain in her arm and tingling/loss of sensation in her immunized arm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Vaccinated on 10.1.2014 Left arm. Approximately 2-3 days later felt pain in arm tingling to hand. Noticed after massage therapy and has not subsided. Used Ice and warm pack with no relief. Had appointment with Chiropractor no relief. Called physician on 10.27.14 talked with Nurse. 11.4.14 Seen by physician and placed on prednisone. Feels better in morning but hurts toward evening. (As reported to me by patient)
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Hyperhidrosis, Influenza like illness
Clinical narrative: Sweats, fever, extreme joint and muscle pain, fatigue, flu like symptoms. Foggy brain, mood change. I do not have insurance or I would have gone to doctor.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Mood altered, Myalgia, Pyrexia
Clinical narrative: Sweats, fever, extreme joint and muscle pain, fatigue, flu like symptoms. Foggy brain, mood change. I do not have insurance or I would have gone to doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Injection site R post triceps area swollen, red 12cmx 8cm, very painful awakened me f/b fatigue, headache, naps required, Tylenol, Erythema decreasing by today 11/10 12noon but still movement or light pressure is painful.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Fluid retention, Joint stiffness, Musculoskeletal pain, Tendonitis, X-ray limb
Clinical narrative: FIRST NOTICED SHOULDER JOINT PAIN AND STIFFNESS ABOUT 1.5 hours after administration.  This continues to worsen over next few days to the point where even minimal pressure on my extremity caused pain, and rom was significantly decreased despite attempts with anti-inflammatories and rom exercises.  Saw occ health after 1week, started Aleve and tramadol and PT exercises,  after still worsening symptoms had an xray and MRI on 10/15 revieled small fluid collection and tendonitis.  Saw orthopedic on 10/22 recieved steroid injection.  48 hours later pain improved and rom improved.  Began PT biweekly and at home.  11/6. Noticed pain worsening again.  Today 11/10 pain is present, not debilitating but worse than yesterday and the day before.  I am still on modified duty at work and see the orthopedic again on 11/12.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Muscle tightness, Tic
Clinical narrative: Facial tics (no motor).  Rapid progression of clenching of the neck muscles so that the neck tendons are visible, opening his moth wide open, and a lifting of his eyebrows. This happens about 4-5 times consecutively. These tics occur frequently throughout the day.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: 4 days after uneventful vaccine administration, client's left arm became painful from shoulder to hand, radiating to pectoral muscles and into axillary area.
Age: 0.62
Sex: F
Vaccine: FLU4
Symptoms: Irritability, Rash erythematous, Urticaria
Clinical narrative: Vaccine given 11/6/14 about 9 AM, child was fussy that night mom gave TYLENOL about 10:30-11pm -> hives within 1/2 hour of TYLENOL. Mom also notes that she did have red spots around her mouth after the vaccine was given. Child was given BENADRYL about 12 am. No hives since (seen in the office 11/7/14 about 2:45 pm).
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: Shoulder pain, tingling in hand, 'nerve' pain at site if injection. This has been to present time. Will have to see Doctor for further information.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Convulsion, Dizziness, Postictal state, Syncope
Clinical narrative: She felt lightheaded, then fainted and then had a brief seizure, (around 10 seconds.) She was post ictal for around 30 minutes. She completely recovered.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever, Chills, Headache and no appeite lasting till 11.08.2014. Patient stated that she had slight head ache before vaccination. Arm at site remains tender.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Constant left shoulder pain with radiation down arm.  Unable to raise arm over shoulder.  Stinging sensation in hand.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Neuralgia
Clinical narrative: Neuralgia, muscle pain in back, neck and arms.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Typical soreness at injection site immediately after.  Next morning extreme pain in shoulder joint.  Applied ice pack.  No relief.  Three days later, still in pain.  Have flu shot annually, never had any problem.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Somnolence, Syncope
Clinical narrative: Fainting, extreme lethargy and sleepiness.
Age: 1.29
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10cm erythema to lt leg. redness, warm to touch.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Peripheral swelling
Clinical narrative: Arm swelling, pain, fever at injection site and redness.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Pain
Clinical narrative: Patient states that approximately 30 minutes after the vaccine she developed itching in palms of hands and feet that later spread to the back of her legs. Pt then reports generalized body aches and later noticing red raised area at injection site that was painful and itching. Patient states that itching has overall resolved, but that she continues to have generalized body aches and the red area appears to be getting larger and is still raised. Patient unable to tell if area is warm to touch, but states that its is uncomfortable to touch. Patient reports taking diazepam and oxycodone for symptoms with relief.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient states that approximately 30 minutes after the vaccine she developed itching in palms of hands and feet that later spread to the back of her legs. Pt then reports generalized body aches and later noticing red raised area at injection site that was painful and itching. Patient states that itching has overall resolved, but that she continues to have generalized body aches and the red area appears to be getting larger and is still raised. Patient unable to tell if area is warm to touch, but states that its is uncomfortable to touch. Patient reports taking diazepam and oxycodone for symptoms with relief.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Pain in shoulder of vaccinated arm only when lifting arm.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Itching and inflammation at injection site.  Patient allergic to Benadryl, so gave loratidine 10mg.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PT has redness and soreness and hives on arm that vaccination was administered in.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling and itching at injection site. Grew to size of "hockey puck" by the time patient reported to pharmacy on 11/7/14.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Arms, legs, back, no new meds or OTCs. On Bactrim for months, Atripla for months. Had sun distribution. Stopped Bactrim, but it worsened. Refused to stop Atripla but it improved off it.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Fatigue, Headache, Pain, Pharyngeal oedema
Clinical narrative: Throat became seriously swollen. Difficult to swallow. Fever of 101.5, Extreme Fatigue, Body Aches. Severe headache. This lasted for 48 hours.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Throat became seriously swollen. Difficult to swallow. Fever of 101.5, Extreme Fatigue, Body Aches. Severe headache. This lasted for 48 hours.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Pruritus, Rash, Rash erythematous
Clinical narrative: Flushing, itching, developing some red rash spots on arm, back and stomach area, feeling little tightness in throat. Initially difficulty in breathing.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Flushing, itching, developing some red rash spots on arm, back and stomach area, feeling little tightness in throat. Initially difficulty in breathing.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Burning sensation, Flank pain, Impaired work ability, Injection site pain
Clinical narrative: Left shoulder pain, sharp, acute, throbbing,radiating to neck causing burning sensation and then down forearm causing sharp, acute pain with tingling into fingers and cramping of muscles on forearm; same pain then traveled to triceps, to axila and to left flank as well as to left pectoralis muscle. Entire arm is weak, painful to touch. Pain is unrelenting 10 out of 10 (10 being very painful). I have seen 3 medical doctors. I have had 1 shoulder xray, an MRI, and physical therapy since 10/28/2014. I have been prescribed Tramadol, Flexeril, and Daypro with little results. I continue to ice my neck, shoulder and arm. I am on light duty at work down graded from what I usually do as an endoscopy nurse.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Muscular weakness, Myalgia, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Left shoulder pain, sharp, acute, throbbing,radiating to neck causing burning sensation and then down forearm causing sharp, acute pain with tingling into fingers and cramping of muscles on forearm; same pain then traveled to triceps, to axila and to left flank as well as to left pectoralis muscle. Entire arm is weak, painful to touch. Pain is unrelenting 10 out of 10 (10 being very painful). I have seen 3 medical doctors. I have had 1 shoulder xray, an MRI, and physical therapy since 10/28/2014. I have been prescribed Tramadol, Flexeril, and Daypro with little results. I continue to ice my neck, shoulder and arm. I am on light duty at work down graded from what I usually do as an endoscopy nurse.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Tenderness, X-ray
Clinical narrative: Left shoulder pain, sharp, acute, throbbing,radiating to neck causing burning sensation and then down forearm causing sharp, acute pain with tingling into fingers and cramping of muscles on forearm; same pain then traveled to triceps, to axila and to left flank as well as to left pectoralis muscle. Entire arm is weak, painful to touch. Pain is unrelenting 10 out of 10 (10 being very painful). I have seen 3 medical doctors. I have had 1 shoulder xray, an MRI, and physical therapy since 10/28/2014. I have been prescribed Tramadol, Flexeril, and Daypro with little results. I continue to ice my neck, shoulder and arm. I am on light duty at work down graded from what I usually do as an endoscopy nurse.
Age: 56.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood culture, Headache, Malaise, Pyrexia, Swelling
Clinical narrative: Just start to feel sick like I was coming down with something.
Age: 56.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Ultrasound scan, White blood cell count increased
Clinical narrative: Just start to feel sick like I was coming down with something.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Hypoaesthesia oral, Ocular hyperaemia, Palpitations, Thirst
Clinical narrative: PATIENT EXHIBITED MOUTH NUMBNESS, PALPATING THROAT, THIRST, STICKY EYES, BODY SHAKES AND RED EYES. SYMPTOMS BEGAN 4 HOURS AFTER IMMUNIZATION AND LASTED ABOUT 8 HOURS.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: PATIENT EXHIBITED MOUTH NUMBNESS, PALPATING THROAT, THIRST, STICKY EYES, BODY SHAKES AND RED EYES. SYMPTOMS BEGAN 4 HOURS AFTER IMMUNIZATION AND LASTED ABOUT 8 HOURS.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: WHEN PT WAS GETTING DRESSED SHE SUDDENLY HAD A SHARP CONSTANT PAIN THAT WENT DOWN HER ARM.  IT WAS SEVERE FOR 2 DAYS.  NOW IT IS STILL SORE BUT SHE CAN MOVE HER ARM AND IT IS NOT CONSTANT.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Pain and weakness in the left arm from where vaccine was administered, she feels it about one third of the way down from her shoulder to her elbow, no elevated temperature or inflammation, no improvement in symptoms over time.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: NO ADVERSE EVENT. PATIENT WAS PREGNANT AND SHE RECEIVED THE REGURAL FLUVIRIN MDV INSTEAD OF THE PRESERVATIVE FREE FLU SHOT.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed I had been itching arm at what felt like a bug bite. Looked in mirror and there was a large red, raised, itchy area at site of yellow fever injection.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Flank pain, Full blood count normal, Herpes zoster
Clinical narrative: Severe right back and flank pain - diagnosis was shingles.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Disability, Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 70-72 year old female patient. No pertinent medical history reported. Approximately in 2007 (reported as 6 to 7 years ago) the patient was vaccinated with ZOSTAVAX (dose and route unknown). No concomitant medications reported. The physician reported that the patient experienced the worst case of shingles that she had seen after receiving ZOSTAVAX (disability). The patient sought unspecified medical attention. The outcome of shingle was unknown. The causality was not reported for shingles. No product quality complaint involved. The reporting physician considered the event to be serious due to significant disability/incapacity. This case is also related to 1411USA002638 due to same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 70-72 year old female patient. No pertinent medical history reported. Approximately in 2007 (reported as 6 to 7 years ago) the patient was vaccinated with ZOSTAVAX (dose and route unknown). No concomitant medications reported. The physician reported that the patient experienced the worst case of shingles that she had seen after receiving ZOSTAVAX (disability). The patient sought unspecified medical attention. The outcome of shingles was unknown. The causality was not reported for shingles. No product quality complaint involved. The reporting physician considered the event to be serious due to significant disability/incapacity. This case is also related to 1411USA003653 due to same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Client received flu shot and developed hives to arm and left side of face. C/o itching hx of allergied (not eggs). RN adm. BENADRYL 50 mg IM (L) arm, Resolved in 15 min.
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt complained of arm pain 2 weeks post injection. Pt. received FLUVIRIN.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Fever 101, chills.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Deep muscular bursitis.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Received an expired ACTHIB vaccine. No adverse effects. Dose not effective and will need to be repeated.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt stated she has been having arm pain after getting flu shot. She can't lift or move her arm (left arm).
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: C-reactive protein normal, Electroencephalogram normal, Formication, Full blood count normal, Irritability
Clinical narrative: Pt presented to ER approximately 36 hours after imms with c/o ants/bugs crawling on his legs and quadricep tightening and excessive irritability. He was admitted. Events decreased. About 4 days after presentation. Symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Metabolic function test normal, Muscle tightness
Clinical narrative: Pt presented to ER approximately 36 hours after imms with c/o ants/bugs crawling on his legs and quadricep tightening and excessive irritability. He was admitted. Events decreased. About 4 days after presentation. Symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Crying, Electroencephalogram normal, Enzyme level test, Formication, Hallucination, visual
Clinical narrative: Pt presented to ER approximately 36 hours after imms with c/o ants/bugs crawling on his legs and quadricep tightening and excessive irritability. He was admitted. Events decreased. About 4 days after presentation. Symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site pain, Laboratory test normal, Pain, Pruritus, Screaming
Clinical narrative: Pt presented to ER approximately 36 hours after imms with c/o ants/bugs crawling on his legs and quadricep tightening and excessive irritability. He was admitted. Events decreased. About 4 days after presentation. Symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Sleep terror, Toxicologic test normal
Clinical narrative: Pt presented to ER approximately 36 hours after imms with c/o ants/bugs crawling on his legs and quadricep tightening and excessive irritability. He was admitted. Events decreased. About 4 days after presentation. Symptoms resolved.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Muscular weakness
Clinical narrative: Vaccine admin on 11/7/14 - within minutes profuse rhinorrhea; 30 min itching (diffuse), then headache, dizziness; within a few hours paresthesias in fingers and toes progressed to hands and feet. Weakness elbows to fingers and knees to toes bilat. Complaints of entire body feeling "heavy". Redness and induration at injection site slightly larger than a quarter. At 48 hours, weakness and paresthesia (in fingertips/toes) continues.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Rhinorrhoea, Sensation of heaviness
Clinical narrative: Vaccine admin on 11/7/14 - within minutes profuse rhinorrhea; 30 min itching (diffuse), then headache, dizziness; within a few hours paresthesias in fingers and toes progressed to hands and feet. Weakness elbows to fingers and knees to toes bilat. Complaints of entire body feeling "heavy". Redness and induration at injection site slightly larger than a quarter. At 48 hours, weakness and paresthesia (in fingertips/toes) continues.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tachycardia
Clinical narrative: Pt experienced nausea and tachycardia approx 8 hours after receiving high dose Flu shot. Emergency Dept was unsure whether it was a viral illness or adverse reaction.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Noticed redness (3" x 2") area and soreness in Lt deltoid this A.M. Swelling and redness better than at 7:00 AM. Advised TYL. Q 4 hrs. prn for soreness and BENADRYL 25mg x 1 dose. Area very warm to touch. Advised see MD if no better tomorrow.
Age: 54.0
Sex: F
Vaccine: FLUR3
Symptoms: Speech disorder, Swelling face
Clinical narrative: Left facial swelling involving left side of her mouth, impacting her ability to speak clearly. Sx developed and progressed approximately 20 min. after receiving the Flu shot. Went to emergency Department.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: Upper arm - inflammation, redness and itching. Much better today 11-10-14.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Rash and tenderness at site of injection 9 days after vaccines given with fever. Fever/vx reaction concern-rash on leg, here w/mom.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: The patient came back to the pharmacy on 11/7/2014 and complained that the pharmacist gave him a flu shot at the wrong spot (???) on 10/8/2014. He has severe deep muscle pain on his left shoulder, arm and cannot move his arm completely.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Pt had vaccine late morning (11:15 approx) 11/3 called afternoon of 11/3 to say it was red and swollen. Pt took ibuprofen and has applied ice. Came to store 7:30. No other symptoms (no wheeze, swollen lips, cough) spoke with pt 8:10- said to just ice and ibuprofen.
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 unspecified number of patients of unknown age and gender. Since 22-SEP-2014 the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose and route were unknown). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient referring to herself. Patient demographics were not provided. Concurrent conditions, medical history and allergies were not reported. On an unknown date in June 2010 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not reported). On an unknown date in June 2013 (also reported as three years later) the patient stated she developed shingles. The patient sought medical attention and was given as treatment gabapentin. The physician demographics were unknown. No further information was provided. The outcome of the patient developed shingles in "June 2013" was unknown. Additional information is not expected because the patient decline to participate in this report and the reporter details were not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 09-OCT-2014, unspecified amount patients were vaccinated with M-M-R II, lot # reported as K002528, expiry date 18-FEB-2016 (dose, route of administration, were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reproter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Patient reported injection site reaction - red, warm to the touch, hard "knot" under the skin about the "size of a 50 cent piece." Patient stated it was painless and she has been applying ice to the area.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 10-OCT-2014, unspecified amount patients were vaccinated with GARDASIL lot # K001631, expiry date 06-NOV-2016 (dose and route of administration were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reproter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 1 year old patient of unknown gender. Information regarding concurrent conditions and pertinent medical history was not provided. On 03-OCT-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (injection, lot # K003423, expiry date 06-MAR-2016, 1 shot in the left thigh, route unspecified). Concomitant therapies included VAQTA, which was vaccinated at the same time. On an unspecified date, in approximately October 2014, the patient developed a varicella-like blister at injection site after receiving (Merck) VARIVAX. The reaction was reported to the office on 15-OCT-2014. No treatment was given for the adverse event. No lab diagnostics study was performed. The outcome of the event was reported as recovered on an unspecified date of 2014. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to "1 or two" patient of unknown age and gender who in September or October 2014, was vaccinated with improperly stored ZOSTAVAX (dose, route and lot number not provided). No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 09-OCT-2014, unspecified amount patients were vaccinated with VAQTA lot # J014587, expiry date 15-JAN-2016, (dose, route of administration were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 10-OCT-2014, unspecified amount patients were vaccinated with VAQTA lot # J014587, expiry date 15-JAN-2016, (dose, route of administration were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Thi spontaneous report as received from a 65 year old female patient with seasonal allergies. On 07-OCT-2014 the patient was vaccinated with ZOSTAVAX injection (route, dosage, dose number and lot number unknown). Concomitant therapies included lisinopril (manufacturer unknown). The patient reported experiencing on 08-OCT-2014, redness, a rash, itchiness, a lump 'the size and shaped of a chicken egg' and feeling hot at the injection site after receiving ZOSTAVAX. The patient sought medical attention (office visit) but received no treatment. The outcome of the events was reported as recovered on approximately on 22-OCT-2014 (reported as: about two weeks later). Additional information is not expected because there is no permission to contact physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 10-OCT-2014, unspecified amount of patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with a dose of PROQUAD (Merck) (lot number, expiration date, dose, route were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 06-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J005721, expiry date 29-AUG-2014 (also reported as 28-AUG-2014), 0.65 ml) subcutaneously. No adverse effect was reported. Additional information has been requested.