chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Dyspepsia, Dyspnoea, Epistaxis
Clinical narrative: Severe stomach pain on the left side. It felt like acid coming up to my esophagus. The pain was severe like a heart burn from my heart to the left side of my rib cage. I am still not healed. Every year I have nose bleeds that last a month or two after flu shot. I also had shortness of breath. This was reported to the pharmacy I had the flu shot at and also to my doctors office.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Eyelid ptosis, Facial paresis, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Patient experienced symptoms 45 minutes after influenza vaccination, develped right sided arm, shoulder, neck, face and jaw weakness and stiffness. Jaw began to spasm and "lock up". He states he experienced right eye redness and ptosis. Injection was in right deltoid. Symptoms lasted about 24 hours.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Trismus
Clinical narrative: Patient experienced symptoms 45 minutes after influenza vaccination, develped right sided arm, shoulder, neck, face and jaw weakness and stiffness. Jaw began to spasm and "lock up". He states he experienced right eye redness and ptosis. Injection was in right deltoid. Symptoms lasted about 24 hours.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis
Clinical narrative: Pink eye.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Rash
Clinical narrative: Rash.
Age: 43.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site induration, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of paralysis in a 43-year-old female patient who received BEXSERO (batch number 148901, expiry date 1st September 2016). Concomitant products included FLUARIX. On 15th October 2015, the patient received the 1st dose of BEXSERO. On 15th October 2015, 12 hrs after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site induration and injection site pain. On 3rd November 2015, the patient experienced paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis, extensive swelling of vaccinated limb, injection site induration and injection site pain were not recovered/not resolved. The reporter considered the paralysis to be possibly related to BEXSERO. The reporter considered the extensive swelling of vaccinated limb, injection site induration and injection site pain to be probably related to BEXSERO. Additional details were provided as follows: The reason patient was given BEXSERO was due to splenectomy. The patient also received FLUARIX on the same day but in separate arm. The health care professional reported that the patient received BEXSERO and within 12 hours the patient developed pain, swelling and an induration at the injection site. The swelling and pain increased to axillary lymph nodes. Also two and half weeks later patient at the time of reporting had paralysis of the pinky finger in arm where shot was given.
Age: 43.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Lymphadenopathy, Paralysis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of paralysis in a 43-year-old female patient who received BEXSERO (batch number 148901, expiry date 1st September 2016). Concomitant products included FLUARIX. On 15th October 2015, the patient received the 1st dose of BEXSERO. On 15th October 2015, 12 hrs after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site induration and injection site pain. On 3rd November 2015, the patient experienced paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis, extensive swelling of vaccinated limb, injection site induration and injection site pain were not recovered/not resolved. The reporter considered the paralysis to be possibly related to BEXSERO. The reporter considered the extensive swelling of vaccinated limb, injection site induration and injection site pain to be probably related to BEXSERO. Additional details were provided as follows: The reason patient was given BEXSERO was due to splenectomy. The patient also received FLUARIX on the same day but in separate arm. The health care professional reported that the patient received BEXSERO and within 12 hours the patient developed pain, swelling and an induration at the injection site. The swelling and pain increased to axillary lymph nodes. Also two and half weeks later patient at the time of reporting had paralysis of the pinky finger in arm where shot was given.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Pt was seen for a WCC and had a blood draw and Gardasil vaccine given. She did not wait in the room for a few minutes as advised after the vaccine and came out to the front desk to leave felt dizzy and passed out fell from standing position to the floor and hit head off floor.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Patient had an intusseception requiring air enema reduction.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pyrexia
Clinical narrative: Low grade fever, from elbow to the shoulder arm was swollen, very tender at injection site, pain from elbow up to ear lasted approximately 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Nasal congestion
Clinical narrative: Cough, very hard to breathe, wheezy, headache, nasal congestion, extreme fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: Cough, very hard to breathe, wheezy, headache, nasal congestion, extreme fatigue.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration at injection site and erythema over much of upper arm.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: 11/11/15 pt. saw oncologist. Received one dose of ARIMIDEX. Next morning her feet felt like they were asleep. As day went on, she got worse - tingling and numbness. Admitted to hosp., transfer to another hosp. on 11/18/15.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein increased, Herpes simplex serology negative, Immunoglobulin therapy, Muscular weakness, Paraesthesia
Clinical narrative: Patient reports that 10 days after receiving vaccine, he developed tingling sensation in his palms and soles of foot that extended to fingers and toes, followed by weakness in his LE. Patient reports no other symptoms. Patient was evaluated in inpatient setting, started on IVIG, and symptoms began to improve immediately after first dose.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Varicella virus test, White blood cell count increased
Clinical narrative: Patient reports that 10 days after receiving vaccine, he developed tingling sensation in his palms and soles of foot that extended to fingers and toes, followed by weakness in his LE. Patient reports no other symptoms. Patient was evaluated in inpatient setting, started on IVIG, and symptoms began to improve immediately after first dose.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Burning sensation, Cough, Erythema, Oropharyngeal pain
Clinical narrative: Swelling, redness, burning sensation. Followed by sore throat, cough, runny nose, joint pain, mild fever.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rhinorrhoea, Swelling
Clinical narrative: Swelling, redness, burning sensation. Followed by sore throat, cough, runny nose, joint pain, mild fever.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Hallucination, Paranoia
Clinical narrative: Hallucination and paranoia that lasted for about one hour and then went away on its own. Has never had these feelings occur before or since.  Did not seek medical care.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle pain, persistent for several weeks.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: Swelling, hot to touch, welted and spreading.  Area 2x1 eventually reached 4" of redness.  Gave Benadryl and ibuprofen.  Neither seemed to do anything.  Also put on hot packs to area.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Electromyogram, Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Guillain Barre Syndrome, while traveling; developed diarrhea followed by ascending weakness - required mechanical ventilation.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Hepatomegaly, Laboratory test abnormal, Liver injury, Musculoskeletal chest pain
Clinical narrative: caught a bad cold soon after I was vaccinated, and when the cold was slightly over. It left me with severe pain inside my rib cage spreading to my back. The doctor did tests. They found I had damage to my liver. I wanted to report about the Flu shot that was given to me. I went to the emergency room and my doctor about this. They told me they don't think my condition came from the Flu shot. They did not run any special tests to prove that it didn't. I know I never had anything wrong with my liver before. I don't drink or smoke. I know I did develop this problem until after I was given the Flu shot.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis
Clinical narrative: caught a bad cold soon after I was vaccinated, and when the cold was slightly over. It left me with severe pain inside my rib cage spreading to my back. The doctor did tests. They found I had damage to my liver. I wanted to report about the Flu shot that was given to me. I went to the emergency room and my doctor about this. They told me they don't think my condition came from the Flu shot. They did not run any special tests to prove that it didn't. I know I never had anything wrong with my liver before. I don't drink or smoke. I know I did develop this problem until after I was given the Flu shot.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arteriogram carotid, Blood folate, Cardiac monitoring, Computerised tomogram, Echocardiogram
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Troponin, Unevaluable event, Vitamin B12
Clinical narrative: None stated.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Entire left arm and hand began to swell within a short time after receiving injection, then became painful and client lost significant range of motion. Was evaluated by his PCP, treated for pain only.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Rotator cuff syndrome, Ultrasound scan, X-ray
Clinical narrative: Severe shoulder pain has lasted 7+ weeks since injection, no prior pain before injection.  Xray, ultra sound and MRI show tear of Supraspinatus tendon.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Eye irritation, Eye pain, Eye pruritus, Eye swelling, Lacrimation increased
Clinical narrative: Extreme sharp pain in right eye; excessive tearing to a great degree; eye swollen; eye felt scratchy, as if scratched by sand.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Ultrasound antenatal screen abnormal
Clinical narrative: I was 5 weeks, 6 days pregnant at the time of the flu shot vaccination.  I had an ultrasound on 11/18/15 which demonstrated growth of only 6 weeks and 2 days, no fetal heartbeat.  Ultrasound on 11/25/15 confirmed previous findings.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PEDIARIX and HEP B given on the same day. No symptoms, signs or treatment.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site abscess, Injection site pain, Injection site warmth
Clinical narrative: Vaccine given upper deltoid bilaterally he had soreness left upper deltoid since injection. Visit 11/24/15. Abscess like lesion, golf ball sized, deep in area of injection. Warm and very tender.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: 11/30/15 pt. called to report persistent soreness of (L) deltoid area where he had rec'd hi-dose flu vaccine injection 7 1/2 wks. ago. Denies other sx - no redness or swelling. Pain occurs with use or (L) arm - not while at rest.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Muscle tightness, Respiratory tract congestion
Clinical narrative: Pt states 3 days after receiving the flu injection, she became congested, with a headache and muscle tightness in her neck.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Very large welt on thigh rt leg. About 6-7 centimeters round hot to touch painful.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm - 11/25/2015 - still have pain.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient came to pharmacy to report numbness and weakness of (R) hand. Symptoms started 2 day after vaccination. Husband stated symptoms were improving. Patient was told to see primary care provider and has appointment scheduled 11/30/15. Patient told to see provider sooner if symptoms do not continue to improve. I called pt.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain
Clinical narrative: Flu shot injected (IM) in left deltoid, then next day she developed symptoms: pain on movement and could not lift or abduct left arm, could not reach overhead to wash hair, or reach to lift: seen on 10/22/15 and 11/19/15.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Reported soreness at injection site for a continued long period of time with body aches and unusually tiredness which has lasted for weeks.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Continued pain in (L) deltoid muscle since vaccine was given on 09-21-2015. Tender upon palpation over injection site.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Patient received flu vaccine at school flu clinic. A few hours after, he developed a diffuse red rash on face and trunk of body. MD reported vesicular in places. He also developed a low grade temp of 100 degrees F.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Reported soreness at injection site for a continued long period of time with body aches and unusual tiredness which has lasted for weeks.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Had vaccine administered at about 0630 on 10/15/15. At around 1230 began to feel dizzy, with chills. Left work and took 600 mg Ibuprofen at home for temp 99.4. At 1500 noted temp to be 102.1. By 1700 temp down to 100.2. On 10/16 saw PCP who prescribed oral prednisone to decrease the immune response which now included body/joint aches and continued low grade fever. Improving but not completely well.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: About an hour after vaccination onset itching on face/head progressing to body wide within 1-2 hours. Took BENADRYL 25mg by mouth about three hours after onset. Some improvement, took x 3 days, 1x/day for resolution. No rash, no hives.
Age: 50.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion
Clinical narrative: Patient has a bruise a little larger than a 1/2 dollar 5 1/2 inches below right shoulder. Patient states she has no pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Bed rest, Blood test, Pain, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Severe all over body pain/ache. Went to Emergency Room. Given fluids and pain med. IV. Went to PCP next day. Did blood work. SED rate very high. On prednisone for 3 weeks add'l blood showed elevated white blood count.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis after flu shot administration. Cleared up after 2 course of antibiotics.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Erythema, Headache, Pain in extremity
Clinical narrative: States Saturday 11/21 had headache, rt arm red, swollen, painful. Today arm feels better but had one episode of diarrhea and dizzy when swimming. Feels ok now.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: States Saturday 11/21 had headache, rt arm red, swollen, painful. Today arm feels better but had one episode of diarrhea and dizzy when swimming. Feels ok now.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Had diarrhea for 2 days after the shot.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Had diarrhea for 2 days after the shot.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Breast tenderness, Diarrhoea, Erythema, Headache, Injection site erythema
Clinical narrative: 5 days after getting shot started as redness at site then moved to Right breast - tender and red. Also had diarrhea, headache, body aches. Started having relief 9 days after getting shot.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain
Clinical narrative: 5 days after getting shot started as redness at site then moved to Right breast - tender and red. Also had diarrhea, headache, body aches. Started having relief 9 days after getting shot.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Muscular weakness
Clinical narrative: On 11-20-15, patient informed me that about 24 hours after the FLUVIRIN injection she experienced muscle weakness in the arm in which the injection was given. Definite weakness in the arm and grip of hand. Not severe but very noticeable. No reaction at injection site. Weakness from right elbow down.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Eyelid oedema, Feeling hot, Injection site paraesthesia
Clinical narrative: Itching and warmth 20-30 min after receiving vaccine about 5-6 hrs later noticed eyes were puffy and arm still sore, has reddened area and still warm  some tingling around injection site - temp 100 degrees today.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itching and warmth 20-30 min after receiving vaccine about 5-6 hrs later noticed eyes were puffy and arm still sore, has reddened area and still warm  some tingling around injection site - temp 100 degrees today.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Dermatitis, Erythema, Malaise, Mobility decreased
Clinical narrative: Pt came into the pharmacy stating she had a severe reaction to PREVNAR. She had cellulitis which required an antibiotic prescription, was ill in bed for a few days and could not move her arm for a few days. Arm still extremely red and inflamed.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vaccination complication
Clinical narrative: Pt came into the pharmacy stating she had a severe reaction to PREVNAR. She had cellulitis which required an antibiotic prescription, was ill in bed for a few days and could not move her arm for a few days. Arm still extremely red and inflamed.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient stated had trouble moving her arm since the shot. She wasn't able to lift anything or use her arm for 1-2 days. Arm extremely sore since then.
Age: 71.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm - 4-6 inches redness, swelling band below injection site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Muscle disorder
Clinical narrative: Pt stated confusion/dizziness shortly after vaccine administration. Pt further stated they had a reaction involving their muscles, pt. unsure if seizures or convulsions. Occurred every 1/2 hour for a while. Did not seek medical advice or consultation. Felt better on 11/27/15 3PM.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Pain
Clinical narrative: Injected in shoulder instead of arm (per pt) resulted in bursitis. Treated with prednisone. Pain came back after she stopped prednisone. Pt have pain when she moves her arm around.
Age: 34.0
Sex: F
Vaccine: FLUR3
Symptoms: Burning sensation, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Presented at 9:00AM for Flu vaccine, known allergy to Flu vaccine, so was given FLUBLOCK. Pt consented to this vaccine. Called back at 11:50AM stating she was starting to itch and breaking out in a red, burning rash. Returned to Employee Health for progression of symptoms. She was sent to ER for generalized whole body rash and itching.
Age: 27.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site bruising, Injection site swelling, Mass
Clinical narrative: Immediately following vaccine administration the patient's arm began to bleed and the arm at the site of administration began to swell up. The patient's arm developed a large lump under the skin.  The patient stated it was not painful.  The patient waited in the pharmacy for 15 minutes with no further reaction. The swelling of the patient's arm began to decrease within the 15 minutes after administration. On 11/30/15 the patient was contacted for follow up.  The patient stated that her arm was not swollen anymore but that there was a bruise at the site of injection.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Breast pain, Breast swelling, Electrocardiogram normal, Loss of consciousness, Peripheral swelling
Clinical narrative: Client reported she passed out at work 3 hours later at 4:55pm. Left arm swelled up like "Popeye's" arm. Pain, itching, and swelling into the left breast, as well. Ambulance was called, no treatment done her B/P, BS and EKG all normal. Client reports the swelling went down a couple days later.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Client reported she passed out at work 3 hours later at 4:55pm. Left arm swelled up like "Popeye's" arm. Pain, itching, and swelling into the left breast, as well. Ambulance was called, no treatment done her B/P, BS and EKG all normal. Client reports the swelling went down a couple days later.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Herpes zoster, Influenza like illness
Clinical narrative: Patient states 2-3 days after vaccination developed shingles rash with pain under armpit. Also reports headache and flu-like symptoms. Pt states rash then progressed to across the chest. Patient states pain has decreased a little.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, X-ray limb
Clinical narrative: Left knee pain/swelling 2 days after receiving influenza vaccine.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: PT had severe flu like symptoms for 3 days post injection. Pt had sore arm starting after injection, expected it to go away after 3 days but it still remains after nearing 30 days. Pt says hurts to lift arm above shoulders. Has not seen MD since incident.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itchy, redness at inj site warm to touch.
Age: 14.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Fear of injection, Pallor, Syncope
Clinical narrative: Client became pale several min. after administration upon standing. then fainted. Client states he does not like needles and did not eat lunch. After client awoke, approx 3 sec staff gave him some water and some food. Staff wanted to observe client longer but once client stated he felt better, parent/guardian wanted to leave. Client accompanied by guardian.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Received flu vaccine. FLUZONE QUADRIVALENT 0.5 ml into (R) deltoid on11/11/15. Notified employee health of shoulder pain 11/23/15, stating it began slowly after vaccination received. States hard to move (R) arm or lift it all up. Cancelled scheduled doctor appt for 11/25/15, but went to ER 11/27/15.
Age: 74.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Nodule, Pain, Pruritus, Skin warm
Clinical narrative: Patient awoke with large knot approx. size of lemon, redness, warm, sore that itches.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Neck pain, Pain, X-ray normal
Clinical narrative: Immediate pain in shoulder, within few hours pain with movement of shoulder/neck.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Lethargy, Polymerase chain reaction, Rash generalised, Scab, Skin lesion
Clinical narrative: Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test
Clinical narrative: Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Eczema, Herpes virus infection, Polymerase chain reaction, Pyrexia, Rash pruritic
Clinical narrative: Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Simplex virus test positive, Skin lesion
Clinical narrative: Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Blister, Injection site reaction, Lethargy, Pyrexia, Scab
Clinical narrative: Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Injection site reaction, Lethargy, Pyrexia, Rash vesicular, Scab
Clinical narrative: Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
Age: 4.0
Sex: M
Vaccine: VARCEL, FLUN4, VARCEL
Symptoms: Lethargy, Pyrexia, Rash generalised, Scab, Skin lesion
Clinical narrative: Fever, Lethargy, progressing to post vaccine vzv with generalized rash/ crusting lesions over whole body.
Age: 4.0
Sex: M
Vaccine: VARCEL, FLUN4, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Fever, Lethargy, progressing to post vaccine vzv with generalized rash/ crusting lesions over whole body.
Age: 4.0
Sex: M
Vaccine: VARCEL, FLUN4, VARCEL
Symptoms: Blister, Pyrexia, Skin lesion, Tenderness, Throat lesion
Clinical narrative: Fever, Lethargy, progressing to post vaccine vzv with generalized rash/ crusting lesions over whole body.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Injection site bruising, Injection site nodule, Injection site warmth, Rash
Clinical narrative: Very large bruise in the injected area, with heat coming from area, chills, small area rash on arm. Treatment: Advil and rest with blankets with no fever.  11/30/15 area still has a knot but minimal in size now.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Headache
Clinical narrative: Headache, dizziness, joint pain of wrists and hands and arms. Joint pain lasted 24 hours. Headache and dizziness continue at time this report completed.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient reports severe pain and inability to raise arm above shoulder.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt reported redness and a lump at injection site from a Zostavax immunization. (unknown time, see above)
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Fatigue, Headache, Oedema peripheral
Clinical narrative: Headache and Fatigue. Took Bayer aspirin. 11/30/2015 7:00 PM left armpit feels sore and swollen. Shot was administered in left arm.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Starting date above, two days after flu vaccine, I have been chronically affected by rhinorrhea, fatigue, sore throat and cough.  These are unusual symptoms for myself and if coincidental, unusually prolonged.  I have never had the flu vaccine in the past and never suffered from the flu since age 20.  I did have a rxn to thiomerosol in an eye drop preparation over 30 years ago. Please let me know what you suspect as an explanation?  I'm very doubtful this is coincidence.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest X-ray abnormal, Dizziness, Fatigue, Fungal infection
Clinical narrative: Chronic fatigue, irregular period, dizzy, fainting, chronic yeast infections, lymph glands swollen, pneumonia, low immune system, allergies, headaches, constant intestinal issues.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Headache, Hypersensitivity, Immune system disorder, Laboratory test
Clinical narrative: Chronic fatigue, irregular period, dizzy, fainting, chronic yeast infections, lymph glands swollen, pneumonia, low immune system, allergies, headaches, constant intestinal issues.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Menstruation irregular, Pneumonia, Syncope
Clinical narrative: Chronic fatigue, irregular period, dizzy, fainting, chronic yeast infections, lymph glands swollen, pneumonia, low immune system, allergies, headaches, constant intestinal issues.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Injection site pain, Pain in extremity, Rash
Clinical narrative: Extreme pain in arm/should (same side as flu shot was given), rash.  Turned out to be shingles and when I looked it up there are many people saying the same thing.
Age: 63.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Blister, Peripheral swelling
Clinical narrative: Patient recieved Prevnar 13 on 11/4/2015 and she come in on 11/30/2015 saying she had swelling of her arm and skin had blisters on it.  She said she was out of state for a month and wanted to let us know.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Mass, Swelling
Clinical narrative: Pt states size of softball then decreased in size to size of hardball over a week.  Still lump seeking treatment.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a lead researcher in the development of the HPV vaccines via online article and refers to 44 female patients of unknown age. The patients medical history and concurrent condition were not reported. The reporter had announcement at the 4th Conference on Vaccination that GARDASIL should not be used. The reporter explained in her presentation that the cervical cancer risk was already extremely low, and that vaccinations were unlikely to have any effect upon the rate of cervical cancer. In fact, 70% of all H.P.V. infections resolve themselves without treatment in a year, and the number rises to well over 90% in two years. Reporter also mentioned the safety angle. All trials of the vaccines were done on children aged 15 and above, despite them currently being marketed for 9-year-olds. So far, 15,037 girls have reported adverse side effects from GARDASIL alone to the Vaccine Adverse Event Reporting System (V.A.E.R.S.), and this number only reflects parents who underwent the hurdles required for reporting adverse reactions. At the time of writing, 44 girls are officially known to have died from these vaccines. The reported side effects include Guillain Barre Syndrome (paralysis lasting for years, or permanently- sometimes eventually causing suffocation), Lupus, seizures, blood clots and brain inflammation. Parents are usually not made aware of these risks. The outcome of Guillain-Barre syndrome, noninfective encephalitis, thrombosis, seizure and systemic Lupus erythematosus was fatal. Causality was not provided. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from two different pharmacists on 03-NOV-2015 and on 04-NOV-2015, referring to a 76 year old female patient. The patient's concurrent conditions included dermographia. The patient had drug reactions or was allergic to codeine, azithromycin, cephalexin, opiates, penicillin (capture in MARRS # 1511USA014721) and sulfa drugs. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial, 0.65 ml, subcutaneously in her left triceps area, lot # K020186, expiration date 27-JAN-2016. Concomitant therapies included sertraline, hydrochloride and an unspecified thyroid medication. It was reported that on 28-OCT-2015 (also reported as "the day after"), the patient noticed her injection site was red and warm, with a red area that "came and went". It was also reported that "one day the redness and raised area was a little more pronounced than other days". Later, on 29-OCT-2015, the patient looked at her injection site under a magnifying glass and noticed that she was developing a rash. This rash was localized to the injection site, was red with rough edges, and it was the size of a half-dollar. On the same date, the patient also started feeling feverish. Then, between that day and the beginning of November 2015, the rash also became itchy and tender. Subsequently, on 04-NOV-2015 at the morning, the rash was still localized to the injection site but had doubled in size. The patient said that she was going to start BENADRYL as treatment. However, at the moment of this report, the patient had not yet received specific treatment for any of the events. At the time of the report, the outcome of rash pruritic, injection site warmth, injection site erythema, rash and rash erythematous was reported as not recovered/not resolved. The outcome of pyrexia was reported as recovering/resolving (also reported as "her fever has subsided"). The relatedness between the events and the ZOSTAVAX was not provided. This case did not involve cancer, the patient did not die, there was no hospitalization and no product quality complaint was involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from two different pharmacists on 03-NOV-2015 and on 04-NOV-2015, referring to a 76 year old female patient. The patient's concurrent conditions included dermographia. The patient had drug reactions or was allergic to codeine, azithromycin, cephalexin, opiates, penicillin (capture in MARRS # 1511USA014721) and sulfa drugs. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial, 0.65 ml, subcutaneously in her left triceps area, lot # K020186, expiration date 27-JAN-2016. Concomitant therapies included sertraline, hydrochloride and an unspecified thyroid medication. It was reported that on 28-OCT-2015 (also reported as "the day after"), the patient noticed her injection site was red and warm, with a red area that "came and went". It was also reported that "one day the redness and raised area was a little more pronounced than other days". Later, on 29-OCT-2015, the patient looked at her injection site under a magnifying glass and noticed that she was developing a rash. This rash was localized to the injection site, was red with rough edges, and it was the size of a half-dollar. On the same date, the patient also started feeling feverish. Then, between that day and the beginning of November 2015, the rash also became itchy and tender. Subsequently, on 04-NOV-2015 at the morning, the rash was still localized to the injection site but had doubled in size. The patient said that she was going to start BENADRYL as treatment. However, at the moment of this report, the patient had not yet received specific treatment for any of the events. At the time of the report, the outcome of rash pruritic, injection site warmth, injection site erythema, rash and rash erythematous was reported as not recovered/not resolved. The outcome of pyrexia was reported as recovering/resolving (also reported as "her fever has subsided"). The relatedness between the events and the ZOSTAVAX was not provided. This case did not involve cancer, the patient did not die, there was no hospitalization and no product quality complaint was involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from two different pharmacists on 03-NOV-2015 and on 04-NOV-2015, referring to a 76 year old female patient. The patient's concurrent conditions included dermographia. The patient had drug reactions or was allergic to codeine, azithromycin, cephalexin, opiates, penicillin (capture in MARRS # 1511USA014721) and sulfa drugs. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial, 0.65 ml, subcutaneously in her left triceps area, lot # K020186, expiration date 27-JAN-2016. Concomitant therapies included sertraline, hydrochloride and an unspecified thyroid medication. It was reported that on 28-OCT-2015 (also reported as "the day after"), the patient noticed her injection site was red and warm, with a red area that "came and went". It was also reported that "one day the redness and raised area was a little more pronounced than other days". Later, on 29-OCT-2015, the patient looked at her injection site under a magnifying glass and noticed that she was developing a rash. This rash was localized to the injection site, was red with rough edges, and it was the size of a half-dollar. On the same date, the patient also started feeling feverish. Then, between that day and the beginning of November 2015, the rash also became itchy and tender. Subsequently, on 04-NOV-2015 at the morning, the rash was still localized to the injection site but had doubled in size. The patient said that she was going to start BENADRYL as treatment. However, at the moment of this report, the patient had not yet received specific treatment for any of the events. At the time of the report, the outcome of rash pruritic, injection site warmth, injection site erythema, rash and rash erythematous was reported as not recovered/not resolved. The outcome of pyrexia was reported as recovering/resolving (also reported as "her fever has subsided"). The relatedness between the events and the ZOSTAVAX was not provided. This case did not involve cancer, the patient did not die, there was no hospitalization and no product quality complaint was involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date June 2016). Concomitant products included MICARDIS, SYNTHROID and ALLEGRA. On 17th November 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In November 2015, less than a week after receiving FLULAVAL QUARIVALENT, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: On 17th November 2015, at 13:31 pm, the patient received a dose of FLULAVAL QUADRIVALENT vaccine in right arm. The patient experienced red area at the injection site, which measured 4.5cm by 4.5cm.
Sex: U
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in an unspecified number of children who received FLUARIX. On an unknown date, the patients received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patients experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to FLUARIX. Additional details were received as follows: This case was previously reported to the manufacturer. The reporter stated that, the clinic provided GlaxoSmithKline Flu vaccine unspecified season to pediatric patients from the age of 3 years and above. The reporter stated that there was increase in frequency and severity of injection site rashes after receiving the vaccine. It was unknown which vaccine was used and how often the event had occurred.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number DX4SN, expiry date unknown). Concomitant products included thyroid medication (nos). On 11th November 2015, the patient received FLUARIX QUADRIVALENT. On 11th November 2015, 6 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site warmth and injection site pain. In November 2015, the patient experienced nerve pain. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved and the outcome of he injection site pain was recovering/resolving and the outcome of the nerve pain was not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth and injection site pain to be related to FLUARIX QUADRIVALENT. The reporter considered the nerve pain to be probably related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient received FLUARIX QUADRIVALENT in right arm. On 12th November 2015, 25 hours after receiving FLUARIX QUADRIVALENT, the patient experienced nerve pain, which was specific to left foot.
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Musculoskeletal pain, Neuritis, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a female patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 7th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the events was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Skin warm
Clinical narrative: Rash at injection site. Approx 4" long and 1" wide. Itchy and warm.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 10 year old patient (patient # 3818) of an unknown gender. No information on patient's medial history, concurrent conditions or concomitant medications was provided. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red round rash 10 cm x 8 cm to right deltoid no swelling, mildly itchy.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given expired vaccine for MMR  Exp date 11/21/15. No reaction or signs/symptoms.