chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Electroencephalogram abnormal, Loss of consciousness, Partial seizures with secondary generalisation, Postictal state
Clinical narrative: My daughter had a seizure.  She felt it start up her left foot and followed up her left arm.  Her head and chest came forward and she passed out.  Had shaking.  My son witness the shaking and he called 911. She then went to the emergency room by squad and they diagnosed possible seizure. She was also in a postictal state following the event.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Tremor
Clinical narrative: My daughter had a seizure.  She felt it start up her left foot and followed up her left arm.  Her head and chest came forward and she passed out.  Had shaking.  My son witness the shaking and he called 911. She then went to the emergency room by squad and they diagnosed possible seizure. She was also in a postictal state following the event.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Bone pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Initial symptom was aching bone and joint pain in L acromion. This pain progressed over 12 hrs to include L clavicle, L neck, L scapula, L arm.  At this time majority of the pain is in L acromioclavicular joint and L upper back.  Pain increases great with lifting of L arm.  Range of motion is mildly affected due to pain at this time.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Initial symptom was aching bone and joint pain in L acromion. This pain progressed over 12 hrs to include L clavicle, L neck, L scapula, L arm.  At this time majority of the pain is in L acromioclavicular joint and L upper back.  Pain increases great with lifting of L arm.  Range of motion is mildly affected due to pain at this time.
Age: 46.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Myalgia
Clinical narrative: Muscle soreness upon lifting arm that still continues (left arm).
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient described red, swollen, itchy, warm sensation below site of injection.
Age: 1.1
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Dermatitis diaper, Pyrexia, Rash
Clinical narrative: Fever on 9/5 up to 102.6. Rash to trunk and diaper area. Temp 99.2 on 9/8.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Arm sore last night - no rash. This AM c/o arm sore; mom noticed red raised hive type rash patch on Lt upper arm at site of FLUZONE injection; no itching; no welts. 7 x 10 cm this AM at office appt. Dx local reaction to Flu vaccine; no systemic reaction.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Arm sore last night - no rash. This AM c/o arm sore; mom noticed red raised hive type rash patch on Lt upper arm at site of FLUZONE injection; no itching; no welts. 7 x 10 cm this AM at office appt. Dx local reaction to Flu vaccine; no systemic reaction.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Hypotonia, Penis disorder
Clinical narrative: Flaccid, shrunken penis. The adverse event occurred the day after the initial GARDASIL vaccine and noticed after working out moderately (gym) and using the restroom. The event continued during, after shower & through evening. This has never happened before under any other conditions. My son was verbally & noticeably shaken & scared. Normal the following morning.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Lip oedema, Ocular hyperaemia
Clinical narrative: Presented to medical at 2109 25AUG11 with lower lipidemia and B/L eye redness/injection. No rashes, tongue edema or airway involvement. Given BENADRYL 50mg po q6h x 3 days and Ranitidine 150mg po q12h x 3 days. Complete resolution of sx in 24 hours. No family history of vaccine rxns or allergies. No prior rxn to influenza vaccine.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Ammonia normal, Blood electrolytes normal, Convulsion, Electroencephalogram normal, Loss of consciousness
Clinical narrative: Afebrile seizures (2) within 48 hours of receiving immunizations. Seizures were brief, generalized with loss of consciousness.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Lymph node pain, Myalgia, Respiratory tract congestion
Clinical narrative: Congestion, pain in lymph nodes in neck, joint pain, muscle pain, dizziness (subsided after approx 15 min).
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site inflammation, Injection site pain, Skin discolouration, X-ray limb normal
Clinical narrative: Lt arm was sore & at the injection site discoloration of skin & a spot at the injection site pt visited MD after 2 weeks of pain. MD. diagnosis inflammation of soft tissue on upper Lt arm (shoulder) treatment with MEDROL.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Pt. claims her arm is very sore & has a quarter size bruise. She also says the next day she had a fever, chills, & vomiting.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Dosing error. FLUZONE (6 months-36 months) given to pt instead of 3 or older FLUZONE formulation. Pt. contacted another dose of 0.25 mL FLUZONE given to make immunity of 0.5 mL dose.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Symptoms appeared 8-30-11. Cellulitis spread from deltoid to elbow (red/swollen and soreness).
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN3, IPV
Symptoms: Electroencephalogram, Tic
Clinical narrative: Complex tic/movement since receiving vaccines. He purses his lips & extending arms/legs quickly - lasts few seconds - episodes occur every few minutes.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: She fainted.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered 8/31/11. The following 2 days with extreme fatigue and then developed redness, warmth and swelling at site.
Age: 1.19
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Hypophagia, Pyrexia
Clinical narrative: Fever Wed AM 09/07/11, diarrhea today 09/08/11 - fever mod. 101 degrees-102 degrees not wanting to drink or eat. Only giving TYLENOL. RN expressed to call Doctor for appointment to r/o any other possible infections.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash 2 wks, oral steroids, oint (Rx), BENADRYL.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Erythema, Hyperhidrosis, Pruritus, Skin warm
Clinical narrative: Red streaks down both arms itching, hot, sweaty, clammy.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Local reaction, Rash
Clinical narrative: Local reaction Lt arm, rash 4.5 x 3.0 cm length to MCV4.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed a 5x3 cm area of swelling & redness at injection site (right thigh).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Musculoskeletal stiffness
Clinical narrative: When pt got shot, first instinct was stiffness on arm immediately. After 3-4 hrs of the shot, pt noticed there's bruises underneath the skin, it's getting darking everyday. Pt's on blood thinner (EFFIENT 10mg). Stiffness last about a day, and now stiffness is gone but bruises underneath skin is getting darker each day. Pt got flu shot before w/o any problem.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: 4 hours post FLUMIST administration, patient developed red, raised urticaria on (L) inner leg. Seen in office 9/7 AM - few small wheals noted on (L) leg. BENADRYL given x2 given. Denied respiratory distress, headache & fever.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chest discomfort, Chills, Cough
Clinical narrative: Coughing at 4:45 PM, Hoarseness worsening for next hour. Chest tightness and shortness of breath starting at 5:00 PM.  No appetite for dinner. Chills & fatigue starting at ~7:30 PM.  Red eyes noticed at 8:00 PM.  Severe weakness, chills, and inability to stand and function at ~8:30.  Vomiting at 8:30.  Felt somewhat better after vomiting 3 times.  Fever of 102.2 and severe weakness/chills at 10 pm.  Slept through night, severe headache, fatigue, and weakness in the morning but fever down.  No medication taken. Was at store during vomiting and weakness.  Ambulance was going to be called b/c I couldn't stand up to check out or even use phone to call family, but was able to drive home after vomiting. Still feeling weak with headache at 11:40 on 9/14/2011 - stayed home from work.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dysphonia, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: Coughing at 4:45 PM, Hoarseness worsening for next hour. Chest tightness and shortness of breath starting at 5:00 PM.  No appetite for dinner. Chills & fatigue starting at ~7:30 PM.  Red eyes noticed at 8:00 PM.  Severe weakness, chills, and inability to stand and function at ~8:30.  Vomiting at 8:30.  Felt somewhat better after vomiting 3 times.  Fever of 102.2 and severe weakness/chills at 10 pm.  Slept through night, severe headache, fatigue, and weakness in the morning but fever down.  No medication taken. Was at store during vomiting and weakness.  Ambulance was going to be called b/c I couldn't stand up to check out or even use phone to call family, but was able to drive home after vomiting. Still feeling weak with headache at 11:40 on 9/14/2011 - stayed home from work.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Ocular hyperaemia, Pyrexia, Vomiting
Clinical narrative: Coughing at 4:45 PM, Hoarseness worsening for next hour. Chest tightness and shortness of breath starting at 5:00 PM.  No appetite for dinner. Chills & fatigue starting at ~7:30 PM.  Red eyes noticed at 8:00 PM.  Severe weakness, chills, and inability to stand and function at ~8:30.  Vomiting at 8:30.  Felt somewhat better after vomiting 3 times.  Fever of 102.2 and severe weakness/chills at 10 pm.  Slept through night, severe headache, fatigue, and weakness in the morning but fever down.  No medication taken. Was at store during vomiting and weakness.  Ambulance was going to be called b/c I couldn't stand up to check out or even use phone to call family, but was able to drive home after vomiting. Still feeling weak with headache at 11:40 on 9/14/2011 - stayed home from work.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Pallor, Rash macular
Clinical narrative: Pt w/ erythematous, blanching macular rash.  Otherwise well.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain
Clinical narrative: Pt has pain and aching at the location where the vaccine was administered. No erythema or vesicle. This began 3-4 days after vaccination with Zostavax and continues today. Still very sensitive to the touch.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pruritus, Rash, Rash vesicular, Skin lesion, Vaccination complication
Clinical narrative: CLIENT PRESENTS IN CLINIC TODAY WITH VARICELLA RASH.  FEW LESIONS ON ARM AND CHEST.  MOM REPORTS SHE NOTICED HER SON ON MAY 15 BREAKING OUT IN RASH ON HIS CHEST AND SPREADING TO HIS ARMS LEGS AND BACK. HE ALSO COMPLAINED WITH ITCHING MOM TOOK CLIENT TO DR TODAY  DR DX VARICELLA RASH REACTION TO VARICELLA VACCINE TREATED IN OFC WITH BENADRYL INJECTION
Age: 26.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Computerised tomogram, Electromyogram, Eyelid ptosis, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: DROOPING LEFT EYE LID, WEAKNESS IN BOTH HANDS AND LEGS. NEUROLOGY DIAGNOSED WITH GUILLAIN BARRE SYNDROME PATIENT PLACED ON IVIG THERAPY FOR 5 DAYS.
Age: 26.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: DROOPING LEFT EYE LID, WEAKNESS IN BOTH HANDS AND LEGS. NEUROLOGY DIAGNOSED WITH GUILLAIN BARRE SYNDROME PATIENT PLACED ON IVIG THERAPY FOR 5 DAYS.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dysphonia, Dyspnoea, Extrasystoles, Headache
Clinical narrative: Redness, soreness, swelling, fever at the shot injection sight, headache, difficulty breathing, weakness, hoarseness, fast heart beat, irregular heartbeat, high blood pressure, skipping heart beat
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Heart rate irregular, Hypertension, Injection site erythema, Injection site pain
Clinical narrative: Redness, soreness, swelling, fever at the shot injection sight, headache, difficulty breathing, weakness, hoarseness, fast heart beat, irregular heartbeat, high blood pressure, skipping heart beat
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Laboratory test
Clinical narrative: Redness, soreness, swelling, fever at the shot injection sight, headache, difficulty breathing, weakness, hoarseness, fast heart beat, irregular heartbeat, high blood pressure, skipping heart beat
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site reaction, Rash erythematous, Skin mass
Clinical narrative: Patient came in to the pharmacy showing a large rash red in color that started just below the shoulder of the right arm and extended to just over the elbow. It was also noted that below the skin she had a lump consistent with s/sx of cellulitis.  At this time the patient's physician provided her an antibiotic and the patient's symptoms have already resolved within 48 hours.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Depressed level of consciousness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: ADOLESCENT BOY FEARFUL OF VACCINATIONS. BECAME PALE AND DIAPHORETIC IMMEDIATELY UPON VACCINATION GIVEN. ASSISTED TO FLOOR AS HE BEGAN LOSING CONSCIOUSNESS. AMMONIA INHALENT USED DAMP CLOTHS TO NECK AND FOREHEAD. AFTER 5 MINUTES CONTINUED TO HAVE LOW LOC, DELAYED CAPILLARY REFILL. O2 APPLIED AND 911 INFORMED.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: ADOLESCENT BOY FEARFUL OF VACCINATIONS. BECAME PALE AND DIAPHORETIC IMMEDIATELY UPON VACCINATION GIVEN. ASSISTED TO FLOOR AS HE BEGAN LOSING CONSCIOUSNESS. AMMONIA INHALENT USED DAMP CLOTHS TO NECK AND FOREHEAD. AFTER 5 MINUTES CONTINUED TO HAVE LOW LOC, DELAYED CAPILLARY REFILL. O2 APPLIED AND 911 INFORMED.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Convulsion, Hyperhidrosis, Laboratory test normal, Metabolic function test
Clinical narrative: Seizure occurred while sleeping. Woke up sweating. Dr. Thinks from Fever.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Metabolic function test normal, Pyrexia
Clinical narrative: Seizure occurred while sleeping. Woke up sweating. Dr. Thinks from Fever.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Crying, Cyanosis, Hypotonia, Musculoskeletal stiffness
Clinical narrative: Child cried, had perioral cyanosis, stiffened briefly and then fell limp in mom's arms.  Episode lasted under one minute.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus
Clinical narrative: MODERATE SYSTEMIC ITCHING.  PT GIVE 50MG OF BENADRYL STAT WHICH RELIEVED SX'S
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13
Symptoms: Skin lesion
Clinical narrative: MULTIPLE SKIN LESIONS ALL OVER BODY 3 WEEKS AFTER VACCINE ADMINISTRATION TREATMENT - ACYCLOVIR (1 TSP POQID X5D)
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Dizziness, Nausea
Clinical narrative: Patient woke up, turned over and was unable to get out of bed because he felt so dizzy and nauseous.  He contacted his physician and was evaluated and prescribed Meclazine (per patient).
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine reaction pt with left upper arm - red warm & swollen also burning & itchy. Dr. just reassure.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Severe Chlls Fever 103.1 Vomiting Headache
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Was seen in emergency on 9/4/11 - arm was swollen, hurting, itching, & red from PNEUMOVAX injection - patient was asked several times if it had been more than 5 years since last dose, she insisted it had been more than 5 years.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Left thigh swollen to quarter-size with redness & fever x 1 day. Swelling persisted about 2 weeks, gradually fading. No other sequelae.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Skin cellulitis treated with Ceftriaxone 1 gm IM & oral antibiotics. Arm soreness.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: After receiving MMR and VARIVAX pt broke out in hives on face and back. Administered BENADRYL and ORAPRED per MD orders. Monitored for 45 mins.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Headache, Nausea, Vomiting
Clinical narrative: 20 min post vaccine, pt c/o headache; mild stom pain. C/O nausea later in evening. Vomited x 2 that night. C/O stom pain next day. Afeb. Headache gone next day. Pt seen by Dr. 9/1/11, stable condition.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Drooling, Head injury, Syncope, Tremor
Clinical narrative: Pt was given HPV #1 and soon after fainted, hit his head on a keyboard nearby and then per mom had "seizure" (body shaking) and drooling. Episode < 1 min.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Pyrexia
Clinical narrative: Fever to 105.6 by ear thermometer (set on oral temp setting) 1 day after receiving PENTACEL (DTaP-Hib-IPV) and Hepatitis B vaccines. Fever lasted until 2 days after immunizations were given. No other major symptoms.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Urticaria - generalized - started the evening after immun. & worsened was tx with BENADRYL 6.25mg po q 6h until rash resolved.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Received varicella vaccine on 8/24/11 left post arm and noticed red, swollen area on 9/03/11 at injection site. Seen my office on 9/07/11 area was 13.5cm x 9.5cm area cellulitis.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Eye swelling, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Started with extreme sore injection spot, itching and swelling. Then large itching welts on my hands and head. By 8/31/2011, I had a headache due to pressure on my head from welts, and face started swelling - eyes swelled shut on 9-1-11 - causing me to miss 3 days of work. Treated with massive steroids (oral & injected).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Started with extreme sore injection spot, itching and swelling. Then large itching welts on my hands and head. By 8/31/2011, I had a headache due to pressure on my head from welts, and face started swelling - eyes swelled shut on 9-1-11 - causing me to miss 3 days of work. Treated with massive steroids (oral & injected).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis - secondary to PNEUMOVAX 23 & FLUVIRIN 2011-2012 formula.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid swelling, erythema and warmth.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Patient received MMR on 8/19/11, first dose & returned to office on 9/1/11 with rash & again on 9/2/11 as rash seemed worse & confluent. It was red/macular & without any other symptoms.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Injection site warm to touch pain/soreness from wrist to shoulder - patient cannot lift arm without pain.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Red area, raised size of apple, non tender appearing 2 days following immunization. Gave BENADRYL & told to do cold compresses. Called pt. 9-6-11 he is doing fine. No nodule now. Only slight bruise.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: Received flu shot 8-31-2011. Sore throat and weakness by 6 pm 8-31-2011. Still weak and sick 9-1-2011. Developed into severe muscle pain, aches and severe chills and weakness by evening. Improving 9-2-2011, but still somewhat sore and weak.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Received flu shot 8-31-2011. Sore throat and weakness by 6 pm 8-31-2011. Still weak and sick 9-1-2011. Developed into severe muscle pain, aches and severe chills and weakness by evening. Improving 9-2-2011, but still somewhat sore and weak.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Dehydration, Dyspnoea, Vomiting
Clinical narrative: Dehydration, vomiting/ABD pain. Emergency Dept breathing difficulty. Pain if consumed food.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 10 minutes after vaccine adm pt c/o rash left abd & (L) arm - Epi. 3 ml SQ given.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Swollen, redness, giving off heat from injection site (L) shoulder.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Swollen, redness, giving off heat from injection site (L) shoulder.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Arm swollen, area hot to touch 3" x 3". KEFLEX 500 Bid, BENADRYL Bid Hydrocortisone Cr.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Patient received a vaccine on 9-6-11. Day of inj. there was a slight bruise at inj. site. This morning 9-14-11, pt. noticed more bruising, a line of red dots near the inj. site and she is sore from the inj. site to her fingertips.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3"x3" swollen, hard, red, painful, hot area right upper outer deltoid area. Tetracycline 500 mg bid x 10 days, Ibuprofen 600 mg bid pc prn #60.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) biceps swollen & red.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediately after injection patient stated he felt dizzy, sweaty and faint - called paramedics.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: 6/13/11 Routine well visit Hep A/PREVNAR 13. 6/28/11 Seen in our office with petechiae/bruising. Platelet count low = 6. Admitted to medical center (Heme-Onc Dept.) for immediate treatment. Later diagnosed with ITP (idiopathic thrombocytopenic purpura).
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Headache, Rhinorrhoea, Vomiting
Clinical narrative: Approx. 40 minutes after receiving vaccines on 9-14-11, client's mother reported that client started vomiting, c/o abdominal pain, headache, and runny nose. She took client to the ER for eval. No treatment given. Mother to observe. Mother will call with follow-up info on 9-16-11.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever up to 103.8
Age: 11.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Facial pain, Fatigue, Influenza like illness, Rash, Respiratory tract congestion
Clinical narrative: Started feeling tired on 9/10, and fell asleep on the couch at a party.  Next moring, woke up with a rash under her left eye, which was dry and hurt.  The developed flu like symptoms; tired, congested, and medicine tried (Benadryl and Tylenol Cold) seemed to relieve symptoms.  PLEASE NOTE:  SHE ALSO HAD A FLU SHOT ON FRIDAY AS WELL.  Not sure which caused it; but she still has some effects from it 5 days later.
Age: 6.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Red and swollen around injection site bruise was about 3 inches long and 4 inches wide.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: WAS NERVOUS BEFORE GETTING INJECTION- BECAME DIZZY AND NAUSEATED IMMEDIATELY AFTER INJECTION GIVEN-RECOVERD IN 10 MINS.
Age: 0.19
Sex: F
Vaccine: RV1
Symptoms: Abdominal pain upper, Irritability, Pyrexia, Vomiting
Clinical narrative: within hours she developed fussiness, fever, inconsolable fussiness, belly pains, vomiting x4
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Decreased appetite, Headache, Nausea, Pyrexia
Clinical narrative: Fever, Headache, Nausea lasted 36 hrs, unable to eat normally for 4 days
Age: 51.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: States "After I got the Tdap vaccine my arm hurt and then my neck started hurting.  My arm is not sore anymore but my neck is still in pain, I can't turn my head without pain so I have to turn my entire body. I haven't done anything out of the ordinary so I was wondering if this could be from the Tdap vaccine."
Age: 0.69
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Very high fever
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Sleep disorder
Clinical narrative: The injection was very painful when given very high on my left arm.  I have experienced pain every night that wakes me several times and requires ibuprofen to lessen -- usually 6 to 8 during the night. During the day the discomfort is less, but still limits my arm movement.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: redness, heat, swelling at vaccination site, myalgias, objective fever, diaphoresis
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site warmth
Clinical narrative: redness, heat, swelling at vaccination site, myalgias, objective fever, diaphoresis
Age: 15.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: fever and body aches
Age: 1.01
Sex: F
Vaccine: FLUX, PPV, VARCEL
Symptoms: Diarrhoea, Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Fever (102.6 F), vomiting, loose stool, rapid pule (184).  Treated at emergency room.
Age: 60.0
Sex: F
Vaccine: YF
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Muscle twitching
Clinical narrative: Uncontrollable muscle twitches followed by grand mal seizure.  (First in patient's life)
Age: 27.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased appetite, Dizziness, Nausea, Pruritus, Syncope
Clinical narrative: Severe itching- treated but not resolved with Benadryl. Fainted once, felt light-headed. Nausea, decreased appetite.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: Fever to 102, screaming the evening of vaccines, Tylenol given.  Patient continued with fever screaming until 9/14/11 where he was fussy, but no fever.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Nausea, Oropharyngeal pain, Skin warm
Clinical narrative: Patient was warm, with a slightly raised body temperature, she had mild nausea and a sore throat.  This lasted for 24 hours.
Age: 0.64
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Occult blood negative, Retching
Clinical narrative: Patient has been having a lot of retching.  He has a Nissan so he can't vomit.  No diarrhea. Mother has been venting the G-tube frequently.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Dyskinesia, Pallor
Clinical narrative: Patient got pale 7 minutes after the shot and it looked like he had a small seizure that lasted about 2 seconds.  His arm jerked and he dropped his phone. He never lost consciousness. I called mom who is a nurse practitioner and she said to give him juice. So I administered juice to him.  He was sitting down the whole time when he got this reaction.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Tremendous pain at injection site.  I had the pneumonia shot once before in 2010 with relatively little pain. The pain was unbearable. It lasted till today 09/14/2011 and the medication Dr prescribed helped a great deal.  The pain medication and other medications were Loritab, Meloxicam, and the equivalent of Claritin.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; fatigue; headaches; dizziness; major soreness in arm; lack of focus; blurry vision. Adverse events still continuing by late evening, despite medication.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Fever; fatigue; headaches; dizziness; major soreness in arm; lack of focus; blurry vision. Adverse events still continuing by late evening, despite medication.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute myeloid leukaemia
Clinical narrative: Acute Myeloid Leukemia, 6 months of chemotherapy
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Acute myeloid leukaemia, Anaemia of malignant disease, Blood fibrinogen increased, Blood immunoglobulin G increased
Clinical narrative: Acute Myeloid Leukemia, 6 months of chemotherapy
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chemotherapy, Cough, Dizziness, Dyspnoea exertional, Fatigue
Clinical narrative: Acute Myeloid Leukemia, 6 months of chemotherapy
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fibrin D dimer decreased, Haematocrit decreased, Haemoglobin decreased, Herpes simplex serology positive, Increased tendency to bruise
Clinical narrative: Acute Myeloid Leukemia, 6 months of chemotherapy
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphocyte count decreased, Neutropenia, Occult blood positive, Pancytopenia, Platelet count decreased
Clinical narrative: Acute Myeloid Leukemia, 6 months of chemotherapy
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Productive cough, Rash generalised, Thrombocytopenia, Vaginal haemorrhage, White blood cell count decreased
Clinical narrative: Acute Myeloid Leukemia, 6 months of chemotherapy
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Redness n swollen with blisters
Age: 14.0
Sex: M
Vaccine: DTP
Symptoms: Paralysis, Pyrexia, Rash
Clinical narrative: Rash, 105.6F fever, loss of use of arm due to muscle paralysis for 4 days.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion
Clinical narrative: Case number PHEH2011US03474 is an initial spontaneous report received from a consumer on 01 Sep 2011: This report refers to a 16-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unknown date. After vaccination, he experienced seizure. No further information was available at the time of this report.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Arthritis reactive, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M increased
Clinical narrative: Case number PHHY2011IN78597 is an initial spontaneous report received from a physician who received information from consumer (patient's husband) on 01 Sep 2011. This report refers to a 33-year-old female patient. She received first dose (day 0) of RABIPUR (batch number unknown) on 08 Apr 2011. She received another four doses of RABIPUR on day 3, 7, 14 and 28. On 05 Aug 2011, she started getting joint pains. Laboratory tests performed on an unknown date revealed erythrocyte sedimentation rate (ESR) of 135/hour; C-reactive protein of 2.4; IgM of 1.84 while IgG and IgA were negative. On an unknown date, she was diagnosed with reactive arthritis. It was also reported that the patient was given treatment for tuberculosis. However, it was unknown if the patient had tuberculosis before taking RABIPUR or not. The event outcome was unknown.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: C-reactive protein increased, Red blood cell sedimentation rate, Tuberculosis
Clinical narrative: Case number PHHY2011IN78597 is an initial spontaneous report received from a physician who received information from consumer (patient's husband) on 01 Sep 2011. This report refers to a 33-year-old female patient. She received first dose (day 0) of RABIPUR (batch number unknown) on 08 Apr 2011. She received another four doses of RABIPUR on day 3, 7, 14 and 28. On 05 Aug 2011, she started getting joint pains. Laboratory tests performed on an unknown date revealed erythrocyte sedimentation rate (ESR) of 135/hour; C-reactive protein of 2.4; IgM of 1.84 while IgG and IgA were negative. On an unknown date, she was diagnosed with reactive arthritis. It was also reported that the patient was given treatment for tuberculosis. However, it was unknown if the patient had tuberculosis before taking RABIPUR or not. The event outcome was unknown.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMR
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Lt arm red, swollen, itchy, uncomfortable after vaccination. Saw MD & prescribed KEFLEX. Mother says arm looked fine by 9-2-11.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: Itching, redness, rash, mild pain.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Neuritis, Pain
Clinical narrative: Admitted to medical center 36 hours after imm given with arm neuritis and pain.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site papule, Injection site rash, Rash, Rash papular
Clinical narrative: 9-9-11 woke up this AM with rash on head, chest & extremities: 3-6 mm erythematous papules.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Pt described a welt at the shot area & a little itching. Pt was OK otherwise.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, CSF cell count normal, CSF protein increased, Cranial nerve disorder, Guillain-Barre syndrome
Clinical narrative: Ascending paralysis & cranial nerve weakness x 5 days. Diagnosed with GUILLAIN-BARRE. Began tx with IVIG x 5 days.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Immunoglobulin therapy
Clinical narrative: Ascending paralysis & cranial nerve weakness x 5 days. Diagnosed with GUILLAIN-BARRE. Began tx with IVIG x 5 days.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness
Clinical narrative: Lightheadedness, shiver.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blindness, Dizziness, Loss of consciousness, Nausea, Syncope
Clinical narrative: The morning after these vaccines, the patient was shaving for the 1st time & got some shaving gel up his nose. He complained of nausea & dizziness & sat down briefly. He then started shaving again and said "Dad, I can't see," he went limp, supported by his Dad. He was unconscious for 1 1/2 min. and "yellow" for 20 min, but recovered completely.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Yellow skin
Clinical narrative: The morning after these vaccines, the patient was shaving for the 1st time & got some shaving gel up his nose. He complained of nausea & dizziness & sat down briefly. He then started shaving again and said "Dad, I can't see," he went limp, supported by his Dad. He was unconscious for 1 1/2 min. and "yellow" for 20 min, but recovered completely.
Age: 9.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Blister, Injection site swelling, Pruritus
Clinical narrative: Swollen area (L) arm at VZV site. Small raised vesicles on face, trunk, back, itching.
Age: 0.4
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an infant patient, who on an unspecified date was accidentally vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) which was not indicated for patients under two years of age when they were supposed to give PREVNAR 13. The physician said they got he numbers confused with the 23 and 13. Follow up information has been received from a physician concerning a 16 week old (gender unknown) patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). There were no adverse reactions. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Throat tightness
Clinical narrative: Dizziness, throat tightness and weakness resolved after PO fluid intake.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dissociation, Dizziness, Flushing, Urticaria
Clinical narrative: Hives, flushing; feeling faint "disconnected".
Age: 0.18
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event
Clinical narrative: Patient was given a PENTACEL and a KINRIX. No adverse reaction occurred.
Age: 4.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 24hrs after injection, injection site red, swollen and itching. 4-5 inch area on left thigh was warm to touch.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Drug exposure before pregnancy, Pregnancy test urine negative
Clinical narrative: Information has been received from a nurse, for VARIVAX (Merck) and GARDASIL, both Pregnancy Registry products, concerning a male neonate whose mother was a 19 year old female with drug allergies to erythromycin, codeine, CECLOR and ampicillin and a history of kidney stones and no illness at time of vaccination, who on 04-NOV-2010 was vaccinated with the third 0.5 ml dose of VARIVAX (Merck) (lot # 666850/0714Z, expiration date 14-MAR-2012) subcutaneously in left arm. Other suspect therapy included the second 0.5 ml dose of GARDASIL (lot # 666121/1778Y, expiration date 19-AUG-2012) intramuscularly in right deltoid on the same day. Concomitant therapy included the second dose of ADACEL (lot # 3281B/A) intramuscularly in left deltoid on the same day, and ORTHO TRI-CYCLEN LO birth control pills. The mother did not test for VARIVAX antibodies before vaccination with varicella-zoster virus (VZV) contained vaccine. On 09-AUG-2011, the mother delivered the normal male baby via C-section since the baby had low heart rate. The neonate weighed 8 lbs. 5 oz. at 42 weeks gestation. There were no congenital anomalies. The baby had respiratory problem and fluid on lung, and was in Intensive Care Unit (ICU) from 09-AUG-2011 to 12-AUG-2011. It was reported that there was no complication or infections or illness during pregnancy and no concurrent medical conditions. There was no other medication used during this pregnancy. The mother's experience has been captured in WAES 1011USA03447. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Caesarean section, Foetal disorder, Human chorionic gonadotropin positive, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a nurse, for VARIVAX (Merck) and GARDASIL, both Pregnancy Registry products, concerning a male neonate whose mother was a 19 year old female with drug allergies to erythromycin, codeine, CECLOR and ampicillin and a history of kidney stones and no illness at time of vaccination, who on 04-NOV-2010 was vaccinated with the third 0.5 ml dose of VARIVAX (Merck) (lot # 666850/0714Z, expiration date 14-MAR-2012) subcutaneously in left arm. Other suspect therapy included the second 0.5 ml dose of GARDASIL (lot # 666121/1778Y, expiration date 19-AUG-2012) intramuscularly in right deltoid on the same day. Concomitant therapy included the second dose of ADACEL (lot # 3281B/A) intramuscularly in left deltoid on the same day, and ORTHO TRI-CYCLEN LO birth control pills. The mother did not test for VARIVAX antibodies before vaccination with varicella-zoster virus (VZV) contained vaccine. On 09-AUG-2011, the mother delivered the normal male baby via C-section since the baby had low heart rate. The neonate weighed 8 lbs. 5 oz. at 42 weeks gestation. There were no congenital anomalies. The baby had respiratory problem and fluid on lung, and was in Intensive Care Unit (ICU) from 09-AUG-2011 to 12-AUG-2011. It was reported that there was no complication or infections or illness during pregnancy and no concurrent medical conditions. There was no other medication used during this pregnancy. The mother's experience has been captured in WAES 1011USA03447. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Caesarean section, Foetal disorder, Maternal exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a nurse, for VARIVAX (Merck) and GARDASIL, both Pregnancy Registry products, concerning a male neonate whose mother was a 19 year old female with drug allergies to erythromycin, codeine, CECLOR and ampicillin and a history of kidney stones and no illness at time of vaccination, who on 04-NOV-2010 was vaccinated with the third 0.5 ml dose of VARIVAX (Merck) (lot # 666850/0714Z, expiration date 14-MAR-2012) subcutaneously in left arm. Other suspect therapy included the second 0.5 ml dose of GARDASIL (lot # 666121/1778Y, expiration date 19-AUG-2012) intramuscularly in right deltoid on the same day. Concomitant therapy included the second dose of ADACEL (lot # 3281B/A) intramuscularly in left deltoid on the same day, and ORTHO TRI-CYCLEN LO birth control pills. The mother did not test for VARIVAX antibodies before vaccination with varicella-zoster virus (VZV) contained vaccine. On 09-AUG-2011, the mother delivered the normal male baby via C-section since the baby had low heart rate. The neonate weighed 8 lbs. 5 oz. at 42 weeks gestation. There were no congenital anomalies. The baby had respiratory problem and fluid on lung, and was in Intensive Care Unit (ICU) from 09-AUG-2011 to 12-AUG-2011. It was reported that there was no complication or infections or illness during pregnancy and no concurrent medical conditions. There was no other medication used during this pregnancy. The mother's experience has been captured in WAES 1011USA03447. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Death
Clinical narrative: This case was reported by a physician and a healthcare professional and described the occurrence of death nos in a 63-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 23 August 2011 the subject received 1st dose of ENGERIX B (1 ml, unknown route, left arm). On 24 August 2011, 1 day after vaccination with ENGERIX B, the subject experienced flu like symptoms. On 01 September 2011 the subject died. The reporter's stated that the subject may have experienced a myocardial infarction, but were not sure if this was noted as cause of death on the death certificate. The subject was hospitalised and the physician considered the events were disabling. The subject died on 1 September 2011. Cause of death was unknown. It was unknown whether an autopsy was performed. The vaccination course with ENGERIX B was discontinued. The physician and healthcare professional considered the events were possibly related to vaccination with ENGERIX B. The physician and healthcare professional reported that two subject's had experienced adverse events with the same lot number of ENGERIX B. This is case 1 of 2 (see case ID A0944514A for details of the other report).
Age: 63.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Death, Influenza like illness, Myocardial infarction
Clinical narrative: This case was reported by a physician and a healthcare professional and described the occurrence of death nos in a 63-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 23 August 2011 the subject received 1st dose of ENGERIX B (1 ml, unknown route, left arm). On 24 August 2011, 1 day after vaccination with ENGERIX B, the subject experienced flu like symptoms. On 01 September 2011 the subject died. The reporter's stated that the subject may have experienced a myocardial infarction, but were not sure if this was noted as cause of death on the death certificate. The subject was hospitalised and the physician considered the events were disabling. The subject died on 1 September 2011. Cause of death was unknown. It was unknown whether an autopsy was performed. The vaccination course with ENGERIX B was discontinued. The physician and healthcare professional considered the events were possibly related to vaccination with ENGERIX B. The physician and healthcare professional reported that two subject's had experienced adverse events with the same lot number of ENGERIX B. This is case 1 of 2 (see case ID A0944514A for details of the other report).
Age: 19.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood pressure increased, Chest pain, Dizziness, Feeling hot, Laboratory test
Clinical narrative: This case was reported by a physician and a healthcare professional and described the occurrence of anaphylactic type reaction in a 19-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included long QT syndrome. The physician was unable to confirm whether the long QT syndrome was ongoing or historical, but reported that there was no note of current medication. On 7 September 2011 at 08:20 the subject received 2nd dose of ENGERIX B (unknown route, left arm). On 7 September 2011, 1 hour after vaccination with ENGERIX B, the subject experienced anaphylactic type reaction, with dizziness, feeling hot, chest pain, nausea, elevated blood pressure and blurred vision. The subject was transported to the emergency room by ambulance. It was unknown what procedures, tests or treatments were performed. The healthcare professional reported that the subject was hospitalized. The physician considered the events were clinically significant (or requiring intervention), and reported that the subject was discharged the same day and referred to follow-up with a doctor. At the time of reporting the outcome of the events was unspecified. The vaccination course with ENGERIX B was discontinued. The physician and healthcare professional considered the events were possibly related to vaccination with ENGERIX B. The healthcare professional noted that the subject may have an allergy to an ingredient of the vaccine, even though it was the subject's 2nd dose. The physician and healthcare professional reported that two subject's had experienced adverse events with the same lot number of ENGERIX B. This is case 2 of 2 (see case ID A0944505A for details of the other report).