chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Rash
Clinical narrative: W/in 24 hours pt's mom noticed rash. Went to fast care and provider diagn. cellulitis & given prescription for KEFLEX.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediately after injection she felt a tingling down her arm. She also noticed pain at injection site.  The pain intensified and patient is still complaining of arm pain that has no radiated to her neck and shoulder area.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Urticaria
Clinical narrative: Hives to vaccinated arm only. No reaction at vaccination site. Feeling hot. Hives located on volar surface of right wrist and forearm.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Woke up with severe nausea and vomiting - progressing to diarrhea.  The next day states had fever and chills. Upper respiratory symptoms within a couple of days of vaccine progressing to difficulty breathing.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory disorder, Vomiting
Clinical narrative: Woke up with severe nausea and vomiting - progressing to diarrhea.  The next day states had fever and chills. Upper respiratory symptoms within a couple of days of vaccine progressing to difficulty breathing.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Wheezing
Clinical narrative: 1 day post FLUMIST administration, student started wheezing. Seen by PCP, treated with albuterol via nebulization and sent home with albuterol inhaler. Seen by PCP for follow-up mild cough possible R.A.D.
Age: 49.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Oedema, Pain, Pain in extremity, Tenderness
Clinical narrative: Pt. c/o tenderness and edema, pain radiating from upper arm. Pain when moving arm in the upper area of arm. Pain to sleep on arm.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Upper left arm has been sore since receiving the shot on October 25, 2012. Pt described some swelling also from shoulder to elbow.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Pt developed rash starting at injection site; now extends over shoulder onto chest.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: Chills, diarrhea, soreness. Resolved in 3 days.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosis: Guillain-Barre syndrome.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Computerised tomogram abdomen normal, Computerised tomogram normal, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Diagnosis: Guillain-Barre syndrome.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Spinal X-ray, Streptococcus test negative
Clinical narrative: Diagnosis: Guillain-Barre syndrome.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Within minutes rash to neck and face, itchy. Rash spread to arms, abdomen and legs. Benadryl 50mg IM given at 2:08 pm. Rash resolving at 1415. 1445 totally resolved.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Blister, Blood test, Furuncle
Clinical narrative: Blisters/boils that developed on arm and legs and a few on her torso.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Grand mal convulsion, Pallor
Clinical narrative: Tonic-Clonic Seizure lasting 3 min. face went pale. Treatment: lowered new hire to ground on left side supported head with pillow and monitored breathing, vital signs taken after seizure 125/68. 911 called at beginning of seizure paramedic arrived and transported new hire to Medical Center.
Age: 24.0
Sex: F
Vaccine: DPP
Symptoms: Hyperaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain immediately after injection, Pain and swelling for 2 days with redness at the site and sensitivity to touch. Taken Tylenol for pain and swelling but no affect. Pain and swelling has gotten worse the past 2 days, not better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left arm swollen, red, hard from shoulder to the elbow. Pt also not moving the arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Bacterial infection, Injection site infection, Injection site swelling
Clinical narrative: Left arm swollen, red, hard from shoulder to the elbow. Pt also not moving the arm.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at injection site 2 weeks post immunization. Indicates "hurt" for 2 days, did not hurt for 1 day & then started hurting again. Reports no pain to touch but when lifting arm.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Headache, vomiting, fever, soreness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site reaction, Joint stiffness, Muscle tightness
Clinical narrative: Pt states on the day following vaccination, she began feeling a "tightening in left shoulder" feeling eventually crossed her back. This progressed to joint pain in distal joints, lower & mid-back. Patient resorted to muscles relaxers.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Erythema, Injection site infection, Pain, Swelling
Clinical narrative: 11-5-12 - Rec vaccine. 11-8-12 - Started hurting (swollen & red). 11-14-12 - To ER - Dx with (R) arm cellulitis & infection at injection site, Rx pain meds and antibiotics prescribed by ER doctor.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Onset between 10/14/12 and 10/20/12- bilateral leg weakness and pain, paresthesia. Saw PCP and neurologist.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: Soreness in (L) arm 1 hour after vaccination. By end of evening - had severe pain and weakness in (L) arm - "felt like someone was hitting arm with a  hammer" patchy red rash from (L) shoulder to (L) elbow developed at same time and became progressively worse for 2 days. Arm was also swollen from (L) shoulder to (L) elbow during this time - "looked like fluid under the skin". Symptoms began improving after 2 days pain-free 10/27/12 pm. Rash, redness, and swelling were all gone 10/28/12 morning.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient went to ER with a whole body rash.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes, Blood glucose, Borrelia test, Full blood count, Vertigo
Clinical narrative: Developed vertigo the evening after she received the influenza vaccine - (injection).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Herpes zoster, Oropharyngeal pain, Rash erythematous, Rash generalised
Clinical narrative: First 30 minutes sore throat, hoarse, evening hrs raised red rash on arm of injection. Next 2 days after gathered red rash on entire body. Next 2 wks. shingles in entire left side of body then rash at that side of spine. This has happened for last 3 yrs after flu shot. Must have activated shingles shot May 3 yrs. earlier given to me.
Age: 1.85
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given 0.5 ml FLUZONE, but is only 2 yrs old and only required 0.25 ml.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fall, Headache, Hypersomnia
Clinical narrative: Sudden onset HA at lunchtime after vac. administered. Had to nap after work. Slept all day Sat, very weak when got up to urinate Sat afternoon. Fell in bathroom. Slept Sun. feels "reasonably okay" today.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Sensation of heaviness
Clinical narrative: Complaints of "nerve" pain down left arm into hand, more heaviness noted in lower arm.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: Within five minutes of receiving the vaccine the patient began to experience symptoms. Symptoms of profuse sweating, tingling in the arms, and legs as well as nausea. 911 was phoned, upon arrival the EMS agent interviewed pt and walked with pt to the ambulance for health readings such as blood pressure. Ten minutes later the patient left in stable condition.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Burning sensation, Erythema, Local swelling, Oedema peripheral
Clinical narrative: Inj given right deltoid.  Right axilla irregularly swollen, burning, red, painful.  Took Benadryl 25mg po.  Redness subsided in 72 hrs.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Chest X-ray normal, Convulsion, Febrile convulsion, Lethargy
Clinical narrative: Patient received immunizations after 6 mo. P.E. the afternoon of 11/5/12. The following day developed congestion. Reportedly had multiple sick siblings at home. The next day she suffered a seizure, reported to last approx. 5 minutes, following which she was lethargic for approx. 20 min. Was taken to ER at Hospital. Temp recorded there was 40.1 degrees C, rectally. PE, CXR & U/A all normal. Diagnosed with viral illness & febrile seizure.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Red blood cells urine negative, Respiratory tract congestion, Specific gravity urine normal, Viral infection, White blood cells urine negative
Clinical narrative: Patient received immunizations after 6 mo. P.E. the afternoon of 11/5/12. The following day developed congestion. Reportedly had multiple sick siblings at home. The next day she suffered a seizure, reported to last approx. 5 minutes, following which she was lethargic for approx. 20 min. Was taken to ER at Hospital. Temp recorded there was 40.1 degrees C, rectally. PE, CXR & U/A all normal. Diagnosed with viral illness & febrile seizure.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: pH urine normal
Clinical narrative: Patient received immunizations after 6 mo. P.E. the afternoon of 11/5/12. The following day developed congestion. Reportedly had multiple sick siblings at home. The next day she suffered a seizure, reported to last approx. 5 minutes, following which she was lethargic for approx. 20 min. Was taken to ER at Hospital. Temp recorded there was 40.1 degrees C, rectally. PE, CXR & U/A all normal. Diagnosed with viral illness & febrile seizure.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Nausea, body aches and pains, fever. Diarrhea. Swollen, red left arm where shot was given.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Nausea, body aches and pains, fever. Diarrhea. Swollen, red left arm where shot was given.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Swelling of left leg for 3 weeks, went down to a bump, and by 4 weeks gone.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, IPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events. Inadvertantly given Pentacel, IPV, HIB.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Muscle swelling
Clinical narrative: Swollen muscle at site, with redness and hot to touch. Itching also. I treated area w/cooling ointment and took 2, naproxen sodium, 220 mg every 4 hrs.
Age: 82.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Axillary pain, Chills, Pain
Clinical narrative: Got chills, soreness not so much at injection site, which is considered normal, but very sore underneath upper arm. Painful to raise right arm.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Dizziness, Dizziness postural, Vertigo
Clinical narrative: Extreme dizziness when I sat down in the couch. My head is spinning so hard. This is the first time I've experienced such a feeling. It is so severe. It is so scary. Then as the days progressed it mellowed down but this time the dizziness happens when I'm about to lay down in bed. When I raise or lower down my head from or to down position. After waking up in the morning to turn off the alarm clock my head will moderately spin. And when I get up, I will feel dizziness which I have never experienced in my life. I am a very healthy person and for the first time in my life I am experiencing this dizziness. I am very disappointed and sad if this dizziness will not leave me. It is like incapacitating. When I do stretch out in bed or I am in extreme sigh of relief, my head will spin. Its like when you are experiencing a sexual arousal my head will feel dizziness. It is triggered by head movement and feeling of arousal.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphoria, Dyspnoea, Rash
Clinical narrative: Breathing problems - harsh, dysphoric x 2 days then 10-19 rash noted on Lt upper thigh which has progressed to bilat knees to abdomen, bilat arms.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Flu and PNEUMOVAX given on 11/1/12 in (L) deltoid. Pt has history of (L) partial mastectomy and sentinel lymph node biopsy. A few days later her upper (L) arm became hot, red and tender. Still red on 11/6/12 but improving.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Dysarthria
Clinical narrative: Approx. 2 hrs after rec'ing flu vaccine dev'd gradual onset of dysarthria. No H/A or facial drop. Eval. in Occ. Health by Dr. & sent to ER to r/o poss. TIA. CT of head performed - no acute pathology. BENADRYL 25 mg given. Within 2 hrs. sxs resolved. Had prev. flu vaccines with no problems.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Chills, Pain, Pyrexia
Clinical narrative: Within 5 hr. lost taste, then within 12 hours chills (+) fever. Body pain. Lasted for about 36 hours. After 3 days he was fine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Ear pain, Influenza, Pain
Clinical narrative: Dizziness, vertigo 2 hrs after administration, vertigo continued on & off for 10-12 days. Flu symptoms, fever, body aches, cough, dizziness - no green mucous drainage noted. Earache also.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vertigo
Clinical narrative: Dizziness, vertigo 2 hrs after administration, vertigo continued on & off for 10-12 days. Flu symptoms, fever, body aches, cough, dizziness - no green mucous drainage noted. Earache also.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Headache, Pain, Rash erythematous, Rash pruritic
Clinical narrative: The morning after receiving vacc. she reports feeling "achy, lousy and headachy" - which resolved later in the day. At the end of the day she noticed a bright red, itchy rash on left arm. Comes to office on day 3. Treatment: Antibiotic cephalexin 500mg 1 cap. every 12 hrs x 5days, cool compresses. Watch for worsening s/s.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Pt reported that last year, about a week after receiving the ZOSTAVAX, she developed a painful "shingles-like" rash on her face and neck. Over the course of a few months, it migrated down to her upper chest. A year later she still has pain and sensitivity on her chest that has not improved.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 8 1/2 x 7 cm swelling, pain right upper arm.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Patient has pain around injection site with arm numbness and inability to raise arm above chest.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: Pt developed malaise, nausea, light headed, persisted till next day-  similar to reaction to first HPV vaccine in August.
Age: 89.0
Sex: F
Vaccine: FLUX
Symptoms: Bed rest, Body temperature increased, Bone pain, Cough, Dysphagia
Clinical narrative: Temp 102. Sore throat. Cough. Sinus congestion. Bone aches. Complete exhaustion. Unable to swallow (1 day). Bed rest and liquids.
Age: 89.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: Temp 102. Sore throat. Cough. Sinus congestion. Bone aches. Complete exhaustion. Unable to swallow (1 day). Bed rest and liquids.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Cystitis-like symptom, Myalgia, Oral herpes
Clinical narrative: Began with what I thought was a UTI as I had cystitis type symptoms, then within 24 hrs, my fingers and toes started tingling and feeling of a weird sensation.  Soon thereafter, my muscles started to have shooting pains, and I had some tingling of my lips.  The muscle pains were so intense that I had to take several warm baths for palliative relief and pain killers to cope with the pain.  I missed work from Thursday thru Friday, and thought I had the weekend to get better.  Sunday night told me differently and I was able to see my Nurse Practitioner.  I was released to return to work on 11/8/2012.  I was till a bit weak, but began to gain strength and worked 2 days.  The following weekend was a 3 day weekend, which I took to rest my achy muscles.  Finally, on the 15th I felt like I was back to my old self.  I have a fever blister now, which I typically get at the end of an illness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral, Sensory disturbance, Urinary tract infection
Clinical narrative: Began with what I thought was a UTI as I had cystitis type symptoms, then within 24 hrs, my fingers and toes started tingling and feeling of a weird sensation.  Soon thereafter, my muscles started to have shooting pains, and I had some tingling of my lips.  The muscle pains were so intense that I had to take several warm baths for palliative relief and pain killers to cope with the pain.  I missed work from Thursday thru Friday, and thought I had the weekend to get better.  Sunday night told me differently and I was able to see my Nurse Practitioner.  I was released to return to work on 11/8/2012.  I was till a bit weak, but began to gain strength and worked 2 days.  The following weekend was a 3 day weekend, which I took to rest my achy muscles.  Finally, on the 15th I felt like I was back to my old self.  I have a fever blister now, which I typically get at the end of an illness.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Computerised tomogram head normal, Convulsion, Fall, Full blood count normal, Laboratory test normal
Clinical narrative: Patient waiting in line at fast food restaurant.  Became stiff, fell to floor, tonic clonic movements lasting 30-40 sec.  Brought to ER for further eval, no further problem following seizure.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Musculoskeletal stiffness, Tonic clonic movements
Clinical narrative: Patient waiting in line at fast food restaurant.  Became stiff, fell to floor, tonic clonic movements lasting 30-40 sec.  Brought to ER for further eval, no further problem following seizure.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site pain, Injection site pruritus
Clinical narrative: Child was sent home from school due to Left arm pain and itching at flu shot injection site.  Child rec'd flu shot on 10-25-12.  Child is also coughing. Cetirizine 5mg q day x 5-7 days.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Haemorrhoids, Idiopathic urticaria
Clinical narrative: Urticaria daily for more than 3 weeks.  Required antihistamines and steroids and allergist referral.  Diagnosis there was idiopathic urticaria but still in process of workup. Also developed hemorrhoids. Unclear whether any of the above related to HPV vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Rash macular
Clinical narrative: Increasing area of induration, macular, erythema, pain. No focal papular lesions. Area size 6 inches x 4 inches upper arm.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Pain in extremity
Clinical narrative: Mom reports child sent home from school due to "reaction" of flu shot in Left Upper Arm.  Child rec'd the flu shot on 10-25-12. patient states his arm didn't hurt until today. Pain is in the deltoid. No other complaints. Cetirizine 10mg q day x 5-7 days.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood pressure increased, Dyspnoea, Erythema, Eye swelling
Clinical narrative: An hr after TDap was received patient states difficulty breathing, throat feels like closing up, face turned bright red and swollen, swollen eyes, BP increased. Rapid response called, IV started, Benadryl 50mg IM given, O2 10 liters via mask, Solumedrol 125 mg IV push given. Transferred to ICU due to still complaining of weakness and difficulty breathing.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Intensive care, Swelling face, Throat tightness
Clinical narrative: An hr after TDap was received patient states difficulty breathing, throat feels like closing up, face turned bright red and swollen, swollen eyes, BP increased. Rapid response called, IV started, Benadryl 50mg IM given, O2 10 liters via mask, Solumedrol 125 mg IV push given. Transferred to ICU due to still complaining of weakness and difficulty breathing.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Computerised tomogram, Full blood count, Gait disturbance, Lumbar puncture, Muscular weakness
Clinical narrative: Bilateral lower extremity weakness, difficulty walking, complaining of "heaviness" in legs. Decreased feeling in left lower extremity. Sent to ER for further evaluation.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging, Sensation of heaviness, Sensory disturbance
Clinical narrative: Bilateral lower extremity weakness, difficulty walking, complaining of "heaviness" in legs. Decreased feeling in left lower extremity. Sent to ER for further evaluation.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Within 4 hrs of vaccine, had 5 hrs incessant crying, inconsolability.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal discomfort, Pruritus
Clinical narrative: Employee states she had "discomfort swallowing and itching to chest and face".
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt's sister noticed pt had swelling & redness on arm at administration site but pt is not experiencing any pain or discomfort so had no idea when it started! Arm was very swollen and red; circular, large red area around site of injection; PT DOES NOT KNOW WHEN SX'S BEGAN...I FILLED IN BOXES ABOVE B/C I HAD TO.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Back pain, Burning sensation, Chills, Eye irritation
Clinical narrative: Chills initially.  24 hours after the shot: fever 101, severe body pain, headache, stomach pain, neck and back pain, severe eye burning and body felt to be on fire.  Arm was very swollen and feverish.  This continued 48 hours after the shot.  Saw a doctor at Urgent Care today who diagnosed as a reaction to the shot.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Neck pain, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Chills initially.  24 hours after the shot: fever 101, severe body pain, headache, stomach pain, neck and back pain, severe eye burning and body felt to be on fire.  Arm was very swollen and feverish.  This continued 48 hours after the shot.  Saw a doctor at Urgent Care today who diagnosed as a reaction to the shot.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Chills initially.  24 hours after the shot: fever 101, severe body pain, headache, stomach pain, neck and back pain, severe eye burning and body felt to be on fire.  Arm was very swollen and feverish.  This continued 48 hours after the shot.  Saw a doctor at Urgent Care today who diagnosed as a reaction to the shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Respiratory distress, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: Unresponsiveness, respiratory distress, tonic seizure activity, unsure if patient lost consciousness.
Age: 60.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Anaphylactic reaction, Respiratory arrest, Respiratory distress, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: Unresponsiveness, respiratory distress, tonic seizure activity, unsure if patient lost consciousness.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Vaccine administered 9/13/12. Patient has continued to have soreness and possible tendonitis in arm since that time. MD feels shot may have been administered into tendon.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Induration, Local swelling, Pruritus
Clinical narrative: Swollen, hot, red, itching, harder 2 x 2 in area.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram head normal, Convulsion, Culture urine negative
Clinical narrative: Seizure - prolonged >10 min < 12 hours after receiving PEDIARIX, Hib, PREVNAR, Rotavirus vaccine. Treated with VERSED, ATIVAN, Fosphenytoin EEG was negative.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram normal, Full blood count abnormal
Clinical narrative: Seizure - prolonged >10 min < 12 hours after receiving PEDIARIX, Hib, PREVNAR, Rotavirus vaccine. Treated with VERSED, ATIVAN, Fosphenytoin EEG was negative.
Sex: F
Vaccine: VARZOS
Symptoms: Elective surgery
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who 2 weeks ago (on 25-OCT-2012 approximately) was vaccinated with ZOSTAVAX (dose, lot and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient would be have an elective surgery for other issue unrelated to with ZOSTAVAX. Upon internal review Elective surgery was considered to be medically significant. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 years old female patient with allergy to codeine. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 12-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient received ZOSTAVAX at another facility and experienced headache and small red blisters that were extremely painful on 30-OCT-2012. There were about 10-15 of the blisters that were on the back and right shoulder that showed up 2 weeks ago (30-OCT-2012) and yesterday (12-NOV-2012) more of the small red blisters that were extremely painful on the elbow. The patient went to the emergency room but was not admitted, No treatment was given for the events and no lab diagnostic test was performed. The outcome of small red blisters that were extremely painful and headache was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. The reporting nurse considered the events to be disabling due to patient being in a lot of pain. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Death, Eye pain, Eye swelling, Herpes zoster
Clinical narrative: This spontaneous report as received from an office manager refers to a 72 years old female patient with high blood pressure and osteopenia, and with no drug allergies/drug reactions. The patient was vaccinated with, 0.5 ml ZOSTAVAX (0240AE; expiration date; 15-MAR-2013) on 29-OCT-2012 intramuscularly. No other co-suspects were reported. Concomitant medications included: OCUVITE PRESERVISION. On approximately 01-NOV-2012, about 4 days after receiving the vaccine, the patient developed a "full" case of shingles. The office manager reported that the rash began on the left side of the patient's forehead and spread "very close" to her left eye. The patient experienced pain and swelling of the left eye. The rash continued to spread to the right side of the patient's forehead. The patient went to an unspecified urgent care center and an unspecified "eye center" for treatment on an unspecified date. She was given an unspecified dose of VALTREX to treat the symptoms. The patient was also seen by the Physician Assistant, on an unspecified date. It was reported that there was no laboratory test done. On an unspecified date, the patient told the office manager that her left eye is less swollen, the pain has lessened and that the rash seems to "drying". It was reported that on an unspecified date the patient died. The relatedness for a "full" case of shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 65 years old male patient. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 01-NOV-2012. Other suspect therapies included Influenza a dose of Virus Vaccine (manufacturer unknown) (lot #, dose and route not reported) on 01-NOV-2012. No concomitant medications were reported. The physician reported that the patient had a fever, tremors, shakes, nausea, vomiting after getting the shots. He was seen in the emergency room two days after the getting the shots (on 03-NOV-2012). No treatment was given for the events. The outcome of tremors, shakes, vomiting, had a fever and nausea was unknown. The relatedness for the reported events was not provided for ZOSTAVAX and Influenza Virus Vaccine (manufacturer unknown). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Got vaccine Wednesday 10/24/12. Got Tdap & flu in left arm. Pt did not want in right arm due to lymph issues from cancer. Second shot hurt immediately. Could not lift arm next day. Had rolfing appt for deep tissue massage. Went to acupuncturist. Had some movement on Friday after getting shot. Went on trip came back & saw doctor on Monday (Nov 12th) & indicated it may have nerve damage.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Received influenza vaccine 10/17/12 at 2100 started getting chills, nausea, headache 10/18/12 at 0600. On commute home same sxs & threw up. Treated with ADVIL, TYLENOL, ZOFRAN.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Received preservative free influenza vaccine 10/29/12 at 2:30 pm. Within half hour started experiencing chest pain & SOB. Tried her personal inhaler 2 puffs COMBIVENT without resolution. Went to E.D. 12 lead EKG, Bld work, PEPCID IV; observation. Discharged home.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt received meningococcal and Tdap in right arm 10/9/12 - sometime before Halloween pt noticed she was breaking out in welts at night in that area. Itchy but self resolve - only happening at night.
Age: 4.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 4 years old patient licensed practical with unspecified gender, pertinent medical history or drug reactions/allergies. On 07-NOV-2012, the patient, who was younger than nine years old, was vaccinated with a dose of GARDASIL (0022AE exp 28-SEP-2014). No other co-suspects were reported. No concomitant medications were reported. The patient experienced no adverse effect. No treatment information was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a 12 years old female patient who got her first dose of GARDASIL (dose, route and lot # not reported) on 18-JUL-2011, her second dose on 05-JUL-2012 (dose, route and lot # not reported), and her third dose of GARDASIL (dose, route and lot # not reported) on 05-SEP-2012. No adverse effects reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with dose 1 and dose 2 of GARDASIL (lot # and dose not reported) on 18-AUG-2011 and on 21-AUG-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. There were no known adverse effects. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 years old patient. The patient was vaccinated with a dose of GARDASIL (lot # H012973; exp date 05-MAR-2015) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that GARDASIL was exposed to 72 degrees Fahrenheit for 120 hours and the vaccine was administered to the patient after the temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 23 years old patient. The patient was vaccinated with a dose of GARDASIL (lot # H012973; exp date 05-MAR-2015) on 12-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that GARDASIL was exposed to 72 degrees Fahrenheit for 120 hours and the vaccine was administered to the patient after the temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 years old patient. The patient was vaccinated with a dose of GARDASIL (lot # H012973; exp date 05-MAR-2015) on 12-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that GARDASIL was exposed to 72 degrees Fahrenheit for 120 hours and the vaccine was administered to the patient after the temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
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 a some patients of unknown age. The patients were vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that possibly some patients might have been vaccinated with improperly stored GARDASIL. The vaccines were exposed to -0.5C for 2 hours. No adverse effect was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 0.73
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Dyskinesia, Hyporesponsive to stimuli, Hypotonia, Somnolence, Tremor
Clinical narrative: Early in day after vaccines child's eyes were droopy, mother put child in bed, child's eyes slightly open but not responding as normal - ie no smiles when grandmother walked in after mother left room grandmother saw baby trembling for approximately 2-3 minutes.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. On an unknown date in May 2011 (reported as 18 months ago) the patient was vaccinated with dose 2 GARDASIL (route and lot # not reported) dose and route not reported. No concomitant medications were reported. Nurse reported that a patient was in the office at the time of the report (08-NOV-2012) to receive dose 3 GARDASIL (lot # not reported) which will be late. Dates of administration of dose 1 and dose 2 GARDASIL (route and lot # not reported) were unspecified because the patient received the doses from another healthcare provider. The patient stated dose 2 GARDASIL was administered 18 months ago (on an unknown date in May 2011). No symptoms reported. No other details. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Fatigue, Full blood count normal, Injection site erythema
Clinical narrative: Pt reported redness swelling and warmth at injection site that lasted 3 days. 5 day after injection developed weakness, nausea, fatigue - had f/u office visits 11/12/ & 11/16 - still symptomatic at time of completing report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Metabolic function test normal, Nausea
Clinical narrative: Pt reported redness swelling and warmth at injection site that lasted 3 days. 5 day after injection developed weakness, nausea, fatigue - had f/u office visits 11/12/ & 11/16 - still symptomatic at time of completing report.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Screaming
Clinical narrative: Four hours after receiving vaccines patient started screaming for 20 minutes, local reaction - redness & swelling at site.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash maculo-papular, Rash pruritic, Vaccination site induration, Vaccination site rash
Clinical narrative: Lg. (about 4 cm) area of induration at vaccine site with a few spots. And, about 20 other maculopapular lesions on extremities that are pruritic.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Back pain, Headache, Nausea, Neck pain
Clinical narrative: High fever over 3 1/2 days, nausea, painful joints, pain in neck, lower back, headache.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: High fever over 3 1/2 days, nausea, painful joints, pain in neck, lower back, headache.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt. received ZOSTAVAX on 11-14-12. Niece called 11-16-12 to report/ask about rxn. Woke up at 2 or 3 AM with an itchy, red area at injection site.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Chills, fever, headache, fatigue, painful, sore, red, hot to touch.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Chills, fever, headache, fatigue, painful, sore, red, hot to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Blister, Herpes zoster, Skin ulcer
Clinical narrative: Active onset of shingles - radiating pain across back toward stomach, blisters and sores. Still active.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Oblong rash at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Injection site reaction, Pain in extremity
Clinical narrative: Received Tdap (R) deltoid right after shot felt tingling down area. 1-2 hrs later started to c/o pain (R) palm & numbness let forearm & 5th finger. Ultimately had some weakness. Improving when examined on 11/12/12.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Received Tdap (R) deltoid right after shot felt tingling down area. 1-2 hrs later started to c/o pain (R) palm & numbness let forearm & 5th finger. Ultimately had some weakness. Improving when examined on 11/12/12.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: (L) arm pain with area & erythema area tender upon palpation & warm. Diag. cellulitis s/p vaccine admin.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain in extremity
Clinical narrative: 5 hours after PNEUMOVAX developed pain & swelling left upper extremity the evening of 11-6 (day after) redness & warmth. Improving as of 11-8.
Age: 1.49
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Dx: Attenuated chickenpox.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Cellulitis, Injection site erythema, Pain in extremity
Clinical narrative: Pt. received vaccine on 11-14-12. That evening her arm was sore. The next AM it was fine. Then today, 11-15-12, after work her arm was sore again and area of injection was red. ROCEPHIN 1 gram was given to pt at 5:43 PM (for cellulitis (R) arm).
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: Pt. received vaccine on 11-14-12. That evening her arm was sore. The next AM it was fine. Then today, 11-15-12, after work her arm was sore again and area of injection was red. ROCEPHIN 1 gram was given to pt at 5:43 PM (for cellulitis (R) arm).
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Patient receive vaccine on 11/12/2012, came back 11/15/2012 with her upper arm swollen, redness, itch, very warm. Advised pt to take TYLENOL to see if it help.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hypertension
Clinical narrative: Dizziness & high blood pressure 20 minutes after vaccine. Pt treated with 0.1 mg clonidine x2. BP reverted to baseline in 3 hrs after office observation.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant who administered vaccine refers to a patient of unknown age. The patient was inadvertently administered an expired dose of GARDASIL (lot #666596/0766Z, Exp date 15-OCT-2012, intramuscular) on 12-NOV-2012. This was the third dose in the GARDASIL vaccination series for the patient. No adverse effect reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure, No adverse event, Syringe issue
Clinical narrative: This spontaneous report ass received from a physician as well as the patient of unknown age. The physician was vaccinated with VAQTA (dose and route not reported) (lot number reported as 0669AE expired date 07-DEC-2014) on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-NOV-2012 while aspirating a prefilled syringe of VAQTA the plunger came out and some of the dose of the VAQTA got on the physician. No adverse event reported. The outcome was unknown at the time of report. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). On 09-NOV-2012, the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65ml, SQ (subcutaneously) lot # 671453/1057AA, exp. date 05-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician, via field representative, refers to a 59 years old female patient with asthma and drug allergies for Penicillin, Sulfa and SEPTRA. On 24-OCT-2012 the patient was vaccinated with a second dose of PNEUMOVAX23 (Product Lot number 1420AA, Expiry date unknown), route not reported. No other co-suspects were reported. No concomitant medications were reported. The patient called into the physician's office within 24 hours of receiving the vaccine complaining of pain in the arm; afterward she had developed the full symptoms of the cellulitis in the entire arm. The cellulitis was diagnosed on 26-OCT-2012. LEVOQUIN (500 mg for 7 days) was given for treatment. The outcome of cellulitis was reported as recovering/resolving. The relatedness for cellulitis is unknown for PNEUMOVAX23. It was reported that this was the patient's second dose; she's has multiple doses at her age because she is asthmatic, and these were recommended by her pulmonologist and not the internist listed in this case. The patient received the second dose of PNEUMOVAX 12 years after the first dose (given in 2000). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient without pertinent medical history and no drug reactions. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number reported as H013021, expire date unspecified) subcutaneously on 20-OCT-2012. No other co-suspects were reported. There was no concomitant medication. The patient who received ZOSTAVAX on 20-OCT-2012 came down with shingles. The patient saw her physician (name unspecified) on 22-OCT-2012 and was diagnosed with shingles and received prescription for VALTREX. No diagnostics studies were performed. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The nurse reported that the office has been administering ZOSTAVAX (lot # not reported) subcutaneously in the back of the upper arm (triceps) rather than the deltoid. No adverse event was reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer regarding herself, a female patient of unknown age. Information regarding the patient's medical history was not provided. On 07-NOV-2012 (reported as 'last Wednesday') the patient was vaccinated with ZOSTAVAX. Information regarding lot number, dose number, dose or route was not provided. No other co-suspects were reported. No concomitant medications were reported. Following the injection (On approximately 08-NOV-2012, exact date not reported) the patient experienced injection site discomfort. The patient was told to treat her discomfort at the injection site with ice and to take TYLENOL. On 08-NOV-2012 (reported as 'last night') the patient experienced an unspecified injection site reaction: the patient stated that after the treatment with ice and TYLENOL was completed, she had noticed that by the time she had come home from work, her injection site had become hard, warm red, and raised. No further information was provided. The outcome of injection site discomfort, and injection site became hard, warm, red, and raised was unknown. A reporter causality for injection site discomfort and injection site became hard, warm, red and raised was not provided for ZOSTAVAX. Additional information is not expected.