chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Breath sounds abnormal, Chest discomfort, Depressed level of consciousness, Dysphonia, Heart sounds abnormal
Clinical narrative: Obtunded, diaphoretic, LOC, distant heart and lung sounds, Patient given 0.3mg epinephrine IM and began to respond with weak voice to medical staff. Pt complained of chest pressure and painful respirations. Pt then transferred to hospital.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Painful respiration, Renal failure acute, Renal function test normal
Clinical narrative: Obtunded, diaphoretic, LOC, distant heart and lung sounds, Patient given 0.3mg epinephrine IM and began to respond with weak voice to medical staff. Pt complained of chest pressure and painful respirations. Pt then transferred to hospital.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Rotator cuff syndrome
Clinical narrative: Influenza vaccine administered HIGH in left deltoid. Arm/shoulder was typically sore for first several days; acetaminophen or ibuprofen was effective. Then more significant shoulder pain developed. By 3 weeks post-immunization, "rotator cuff" symptoms were evident and NSAIDS had no impact. Indomethacin, Naproxen, and Nabumetone were all used with no relief of shoulder pain.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: Patient describes a rash that appeared on arms and legs.  She felt feverish, and tired. Rested all day and the rash is going away. She is feeling better at 5pm.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site reaction, Joint range of motion decreased, Myalgia
Clinical narrative: Immediately following injection - muscle pain at injection site and hours later painful with movement for 5-6 days. Then pain was felt deeper and in the joint rather muscle. This started 10/12/13 and continued to progressively get worse. ROM limited and very painful.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Immediately following injection - muscle pain at injection site and hours later painful with movement for 5-6 days. Then pain was felt deeper and in the joint rather muscle. This started 10/12/13 and continued to progressively get worse. ROM limited and very painful.
Age: 28.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever of 102 degrees F, chills, muscle aches, fatigue. Administered 400 mg Ibuprofen to reduce fever.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: DIAGNOSED WITH STAPH AT THE INJECTION SITE. ON 10/23/2013 MY LOW FEVER PROGRESSED TO 102 DEGREES BY MIDNIGHT. INJECTION SITE RED & SWOLLEN APX 2 INCHES DIAMETER. ON 10/25/2013 THIS PROGRESSED TO A 4 INCH HARD, RED WELT SURROUNDED WITH REDNESS 10CM X 14CM AS MEASURED BY DOCTOR. REDNESS EXCEEDED THIS MEASUREMENT BY 10/26 & 10/27. ON 10/25 I WAS PRESCRIBED AN ORAL ANTIBOTIC & GIVEN AN ANTIBOTIC INJECTION WHICH WAS REPEATED 10/26 & 10/27.  REDNESS STARTED TO RECEDE BY 10/28. MOST REDNESS IS GONE AS OF 10/29 BUT AS OF 10/30 THERE IS STILL A RED/PINK AREA ABOUT 4 INCHES X 5 INCHES.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Staphylococcal infection, Urticaria
Clinical narrative: DIAGNOSED WITH STAPH AT THE INJECTION SITE. ON 10/23/2013 MY LOW FEVER PROGRESSED TO 102 DEGREES BY MIDNIGHT. INJECTION SITE RED & SWOLLEN APX 2 INCHES DIAMETER. ON 10/25/2013 THIS PROGRESSED TO A 4 INCH HARD, RED WELT SURROUNDED WITH REDNESS 10CM X 14CM AS MEASURED BY DOCTOR. REDNESS EXCEEDED THIS MEASUREMENT BY 10/26 & 10/27. ON 10/25 I WAS PRESCRIBED AN ORAL ANTIBOTIC & GIVEN AN ANTIBOTIC INJECTION WHICH WAS REPEATED 10/26 & 10/27.  REDNESS STARTED TO RECEDE BY 10/28. MOST REDNESS IS GONE AS OF 10/29 BUT AS OF 10/30 THERE IS STILL A RED/PINK AREA ABOUT 4 INCHES X 5 INCHES.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUN4, SMALL, TYP
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Rash, all over body, started Friday, 25 Oct 13, morning at 0600. Small red bumps that itches and is annoying. Member seen by Dr on 30 Oct 13, placed on 48 hours quarters, treated with medication and permanently exempted from Smallpox vaccine.
Age: 0.53
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased
Clinical narrative: Underarm temperature of 101 F for about 15-20 hours. Controlled with infant Tylenol.
Age: 0.17
Sex: M
Vaccine: HEP, HIBV, OPV, PPV, RVX
Symptoms: Abnormal behaviour, Crying, Pain
Clinical narrative: Our baby received all his standard 2-month-old shots.  He was fine for the first few hours after the vaccines, but then around 4 or 5 hours after he received his shots, he started crying hard and seemed in pain.  He cried for 4.5 hours, which was very unusual for him.  We gave him infant Tylenol after he started crying, and then a second dose again 4 hours later.  It was after the second dose, and it being late at night, that he was finally able to fall asleep.  He woke up fine the next day though and seemed back to his normal self.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Altered state of consciousness, Bacterial test negative, CSF white blood cell count positive, Drug screen, Encephalitis
Clinical narrative: Malaise, fever at onset. Sought help in ER 10/20/2013. No dx given. 10/23/2013, altered consciousness, probable meningitis or encephalitis.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Full blood count, Lumbar puncture, Malaise, Meningitis, Pyrexia
Clinical narrative: Malaise, fever at onset. Sought help in ER 10/20/2013. No dx given. 10/23/2013, altered consciousness, probable meningitis or encephalitis.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Urine analysis, White blood cell count normal
Clinical narrative: Malaise, fever at onset. Sought help in ER 10/20/2013. No dx given. 10/23/2013, altered consciousness, probable meningitis or encephalitis.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death
Clinical narrative: Malaise, fever at onset. Sought help in ER 10/20/2013. No dx given. 10/23/2013, altered consciousness, probable meningitis or encephalitis.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Coma, Death, Laboratory test, Reye's syndrome
Clinical narrative: Malaise, fever at onset. Sought help in ER 10/20/2013. No dx given. 10/23/2013, altered consciousness, probable meningitis or encephalitis.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Blood test normal, Chest X-ray normal, Chills, Cough
Clinical narrative: Chills. Tired. Body very cold. Equalibrium, driving, and brain function decrease. Throat hourse. No fever, no body aches, but body felt "twingy". 10/23 ER found nothing wrong same with PDr. 10/28.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Fatigue, Feeling cold, Impaired driving ability, Mental impairment
Clinical narrative: Chills. Tired. Body very cold. Equalibrium, driving, and brain function decrease. Throat hourse. No fever, no body aches, but body felt "twingy". 10/23 ER found nothing wrong same with PDr. 10/28.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Sensation of heaviness
Clinical narrative: Chills. Tired. Body very cold. Equalibrium, driving, and brain function decrease. Throat hourse. No fever, no body aches, but body felt "twingy". 10/23 ER found nothing wrong same with PDr. 10/28.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, No adverse event, Syringe issue
Clinical narrative: Patient was accidentally injected with a used syringe & needle previously used to administer Flulaval to her daughter, needle was immediately removed & disposed in Sharps container, no immediate reprocussions, no adverse effects or events reported by patient at 48 hours and 96 hours post injection.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea, Heart rate increased
Clinical narrative: Difficulty breathing, hoarseness, fast heartbeat.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eyelid oedema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Wearing long-sleeves, so, I don't know when the whelps started.  Noticed on my hands, bumps appearing on the backs of my hands. Around 3:00 I noticed my arms were affected. By 6:00 PM I was feeling like I couldn't clear my throat. Coughing. I realized I was having an allergic response. I took Zyrtec and a drank a lot of iced tea and water. Eyes started feeling puffy. Before 9:00 PM. I woke with a cough, still tightened throat, eyes still a little puffy, and rash was still very evident. At 5:55 PM on 10/30/2013, same symptoms are present. Additionally, the arms never itched, however, now my neck is and no rash on my neck. I will take Benadryl now that I am not driving. I have to get a flu shot every year in my field of employment (hospital sales). I usually get the Sanofi-Pasteur vaccine and have NEVER had a reaction.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness, Urticaria
Clinical narrative: Wearing long-sleeves, so, I don't know when the whelps started.  Noticed on my hands, bumps appearing on the backs of my hands. Around 3:00 I noticed my arms were affected. By 6:00 PM I was feeling like I couldn't clear my throat. Coughing. I realized I was having an allergic response. I took Zyrtec and a drank a lot of iced tea and water. Eyes started feeling puffy. Before 9:00 PM. I woke with a cough, still tightened throat, eyes still a little puffy, and rash was still very evident. At 5:55 PM on 10/30/2013, same symptoms are present. Additionally, the arms never itched, however, now my neck is and no rash on my neck. I will take Benadryl now that I am not driving. I have to get a flu shot every year in my field of employment (hospital sales). I usually get the Sanofi-Pasteur vaccine and have NEVER had a reaction.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: A lot of swelling and redness at injection site & all lymph nodes very swollen in upper left region of body.  Injection site and nodes painful.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest pain, Cough, Dizziness, Dyspnoea
Clinical narrative: Onset of burning sensation in lungs when inhaling as well with cough, yellowish discharge from eyes. Onsite doctor had me complete one treatment of albuterol nebulizer. After about one hour on initial symptoms, continued to worsen with nausea, headache and dizziness, doctor had epinepherine injected IM, sudden onset of difficulty breathing approximately 5-10 minutes after injection. Inability to take in full deep breath with pain in lower thoracic region. O2 Sat decreased to 83%, tachycardic. Given additional injections of Solu-Medrol, Toradol, and additional nebulizer treatment.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Headache, Hypopnoea, Nausea, Oxygen saturation decreased
Clinical narrative: Onset of burning sensation in lungs when inhaling as well with cough, yellowish discharge from eyes. Onsite doctor had me complete one treatment of albuterol nebulizer. After about one hour on initial symptoms, continued to worsen with nausea, headache and dizziness, doctor had epinepherine injected IM, sudden onset of difficulty breathing approximately 5-10 minutes after injection. Inability to take in full deep breath with pain in lower thoracic region. O2 Sat decreased to 83%, tachycardic. Given additional injections of Solu-Medrol, Toradol, and additional nebulizer treatment.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Painful respiration, Tachycardia
Clinical narrative: Onset of burning sensation in lungs when inhaling as well with cough, yellowish discharge from eyes. Onsite doctor had me complete one treatment of albuterol nebulizer. After about one hour on initial symptoms, continued to worsen with nausea, headache and dizziness, doctor had epinepherine injected IM, sudden onset of difficulty breathing approximately 5-10 minutes after injection. Inability to take in full deep breath with pain in lower thoracic region. O2 Sat decreased to 83%, tachycardic. Given additional injections of Solu-Medrol, Toradol, and additional nebulizer treatment.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia oral
Clinical narrative: Tip of tongue is constantly numb.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Swelling
Clinical narrative: About 10 minutes after shot there was burning and that evening it swollen and very red.
Age: 49.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Burning sensation, Erythema, Swelling
Clinical narrative: ABOUT 10 MINUTES AFTER SHOT THERE WAS BURNING AND THAT EVENING IT WAS SWOLLEN AND VERY RED.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood test, Chills, Erythema, Flushing
Clinical narrative: Rash/redness on arms, flushed in face and tremors in hand where vaccine administered. Severe stomach cramps, fainting, headache leg pain, chills, shakes, fever, aching muscles, frequent urination, feeling of throwing up and general feeling unwell. These symptoms occur 4-5 times per week.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Rash/redness on arms, flushed in face and tremors in hand where vaccine administered. Severe stomach cramps, fainting, headache leg pain, chills, shakes, fever, aching muscles, frequent urination, feeling of throwing up and general feeling unwell. These symptoms occur 4-5 times per week.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pollakiuria, Pyrexia, Rash, Syncope, Tremor
Clinical narrative: Rash/redness on arms, flushed in face and tremors in hand where vaccine administered. Severe stomach cramps, fainting, headache leg pain, chills, shakes, fever, aching muscles, frequent urination, feeling of throwing up and general feeling unwell. These symptoms occur 4-5 times per week.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis
Clinical narrative: Rash/redness on arms, flushed in face and tremors in hand where vaccine administered. Severe stomach cramps, fainting, headache leg pain, chills, shakes, fever, aching muscles, frequent urination, feeling of throwing up and general feeling unwell. These symptoms occur 4-5 times per week.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood test normal, Chills, Flushing, Pyrexia
Clinical narrative: Rash/redness on arms, flushed in face and tremors in hand where vaccine administered. Severe stomach cramps, fainting, headache leg pain, chills, shakes, fever, aching muscles, frequent urination, feeling of throwing up and general feeling unwell. These symptoms occur 4-5 times per week.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Syncope, Tremor, Urine analysis
Clinical narrative: Rash/redness on arms, flushed in face and tremors in hand where vaccine administered. Severe stomach cramps, fainting, headache leg pain, chills, shakes, fever, aching muscles, frequent urination, feeling of throwing up and general feeling unwell. These symptoms occur 4-5 times per week.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nodule, Pain in extremity, Pyrexia
Clinical narrative: Heavy arm pain, chills and fever during the night and somewhat for two days. Arm stayed very painful and with a knot for more than a week.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Conjunctivitis allergic, Eye discharge, Eye pruritus, Injection site erythema
Clinical narrative: Bilateral itchy eyes, watery, redness, yellow drainage. Sxs lasted until 10/20/2013. Redness and swelling of the left arm around injection site. Treated on 10/17/2013.  Prescribed Cephalexin for 10 days to treat cellulitis of left arm. Flu shot was administered subcutaneously, and OTC eye drops for allergic conjunctivitis.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Lacrimation increased, Ocular hyperaemia, Purulent discharge
Clinical narrative: Bilateral itchy eyes, watery, redness, yellow drainage. Sxs lasted until 10/20/2013. Redness and swelling of the left arm around injection site. Treated on 10/17/2013.  Prescribed Cephalexin for 10 days to treat cellulitis of left arm. Flu shot was administered subcutaneously, and OTC eye drops for allergic conjunctivitis.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient reports sharp pain with onset of approximately one week after vaccination which impairs her motility.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/pins and needles in left pinky finger, left wrist, left elbow.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain
Clinical narrative: Intense pain, could not lift arm to even hold a pen, could not lift arm left or right/up or down.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling abnormal, Musculoskeletal stiffness, Paraesthesia, Somnolence
Clinical narrative: Thirty minutes after shot was administered I vomited in the bathroom at work. I suddenly felt dizzy, tingly and very strange. My eye sight was off. I don't know how to explain, not exactly blurry but just cloudy. Felt drowsy and blah all the rest of the day. My arm was very stiff the rest of the day as well.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Vision blurred, Visual impairment, Vomiting
Clinical narrative: Thirty minutes after shot was administered I vomited in the bathroom at work. I suddenly felt dizzy, tingly and very strange. My eye sight was off. I don't know how to explain, not exactly blurry but just cloudy. Felt drowsy and blah all the rest of the day. My arm was very stiff the rest of the day as well.
Age: 1.32
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction. Patient received vaccines that had already been given in the past. Second dose of varicella 10/08/2013 Influenza 10/08/2013. Were not supposed to be administered.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Throat irritation, Use of accessory respiratory muscles, Wheezing
Clinical narrative: Audible wheezing; Retractions o2 sat 80% c/o itchy throat about 15 min post Hep A and Tdap; Re with o prednisone XOPENEX and Epipen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: Erythema multiforme fever > 103 degrees developed 48 hrs. post vaccination.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Paraesthesia
Clinical narrative: Received flu vaccine on 10/1/13 in LFA. Pain at site later in the day going up left side of neck and around the back of neck. Pain not improved and by 10/4/13 had pain in neck and shoulder with tingling in left fingers.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Received flu vaccine on 10/18/13. About 1 hour after the site and surrounding area approx 2" in diameter became red and itchy by 1PM it was size of a tennis ball - hard lump swollen and 2 inches out with pain up the back of neck and to hand.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Neck pain, Pain in extremity
Clinical narrative: Received flu vaccine on 10/18/13. About 1 hour after the site and surrounding area approx 2" in diameter became red and itchy by 1PM it was size of a tennis ball - hard lump swollen and 2 inches out with pain up the back of neck and to hand.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Joint stiffness, Muscle tightness
Clinical narrative: Received flu vaccine on 10/2/13 in LFA and noted tightness in left neck and shoulder. Similar to last year in which I was in bed for a day and 1/2 for painful muscle spasms and unable to move left arm and head.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Ocular hyperaemia
Clinical narrative: Complains of red and burning eye after the flu vaccination.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt dizzy and fainted. According to his mother, patient has anxiety problems, which has  caused fainting before. Patient never had problem with flu shot. Patient received soda from his mom and felt better afterwards.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received flu and pneumovax vaccines 10/15/13 in PCP office. Seen in urgent care on 10/18 and 10/19/13 for R upper arm swelling, redness, warmth, and pain. RX Augmentin 875 mg/125 2x day, Benadryl 50 mg 2xday; Loratadine 10 mg daily.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis redness/warmth/swelling at site of injection of MENACTRA and flu and Tdap vaccines, treated with KEFLEX.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Rash
Clinical narrative: Pinpoint rash dots on left arm. Joint pain (patient has arthritis could be from that) not sure if it is from vaccine.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Oropharyngeal pain, Pyrexia
Clinical narrative: Diarrhea, chronic sore throat, chills and fever.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient reports rash "all over her body" within 24 hours of receiving vaccination.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pruritus
Clinical narrative: About 3 inches below the injection site, developed a 3-4 inch wrap around bruise. Area was itchy. Recommended BENADRYL and ice.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Decreased appetite, Myalgia, Nausea, Oral herpes
Clinical narrative: Fever 101 degrees F, nausea, stomach upset, loss of appetite, muscle aches, fever blister. Pt was affected with these reactions the day of vaccination and recovered fully after 5 days. Had no prior reactions to any other/regular flu vaccines.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 101 degrees F, nausea, stomach upset, loss of appetite, muscle aches, fever blister. Pt was affected with these reactions the day of vaccination and recovered fully after 5 days. Had no prior reactions to any other/regular flu vaccines.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, X-ray normal
Clinical narrative: Patient felt immediate pain upon injection and had trouble  moving arm. Doctor performed x-ray but could not find abnormal markings. Patient diagnosed with bursitis. Prescribed Tramadol for pain.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Injected limb mobility decreased, Injection site pain, Insomnia, X-ray normal
Clinical narrative: Patient felt immediate pain upon injection and had trouble  moving arm. Doctor performed x-ray but could not find abnormal markings. Patient diagnosed with bursitis. Prescribed Tramadol for pain.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Received TDAP. Arm began swelling. Presents 5 days later with 6cm erythematous raised swollen over deltoid. Denies med or vaccine allergies.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Lymph node pain, Pyrexia
Clinical narrative: Cellulitis, fever 24 hrs after vaccine - cellulitis started next day, initially thought, it was just a reaction to vaccine. Fever, tender axillary and cervical lymph nodes on left. Ceftriaxone about 48 hrs after started on doxy another ceftriaxone 72 hrs after.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site rash, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Received flu shot Thursday 10-24-13 (morning), noticed rash on Saturday morning. Bruising at injection site, red rash from injection site to about halfway between shoulder (injection site) and elbow. Patient states rash feels slightly warm to the touch.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient got flu shot (FLUZONE HD) 9/30/13 - patient reports pain in arm and trouble lifting arm today.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient got flu shot (FLUZONE HD) 9/30/13 - patient reports pain in arm and trouble lifting arm today.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site swelling, Injection site warmth, Local reaction, Nausea
Clinical narrative: Local reaction site hot, swollen, and 2 in raised area per pt. description, headache, nausea, no fever. Reported day after injection by pt.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Generalized itching.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Left arm red, hot, and swollen. Redness was spreading so she was given antibiotic by MD.
Age: 0.16
Sex: M
Vaccine: DTAPIPV, HBHEPB, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX vaccine given in (R) thigh at age 8 wk 4 day old.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Feeling hot, Hypoaesthesia oral
Clinical narrative: No reaction for 20 hours - then rash, welts. Head foggy, lip and tongue numb. 2 weeks - joints ache, still head foggy. The Pharmacist said I would have a reaction within the first few minutes if I were going to have one but I had no reaction till about 20 hours after. A rash on my stomach, breasts, back with welting, the injection site was about a 50cent piece size red and swollen. The rash was sensitive but not painful. I felt hot and fatigued. I felt terrible and thought I had gotten shingles, my head was foggy and still is some, my joints now hurt and I do not feel well as I had before the vaccine. I regret getting the vaccine. I hope you include these symptoms as a warning to others.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise, Rash, Urticaria
Clinical narrative: No reaction for 20 hours - then rash, welts. Head foggy, lip and tongue numb. 2 weeks - joints ache, still head foggy. The Pharmacist said I would have a reaction within the first few minutes if I were going to have one but I had no reaction till about 20 hours after. A rash on my stomach, breasts, back with welting, the injection site was about a 50cent piece size red and swollen. The rash was sensitive but not painful. I felt hot and fatigued. I felt terrible and thought I had gotten shingles, my head was foggy and still is some, my joints now hurt and I do not feel well as I had before the vaccine. I regret getting the vaccine. I hope you include these symptoms as a warning to others.
Sex: U
Vaccine: PPV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMVOAX 23, lot #, dose, frequency and route unspecified. Concomitant therapies included PREVNAR, lot #, dose, frequency and route unspecified. On an unknown date the physician vaccinated an unspecified amount of patients with PNEUMOVAX 23, and then used a "booster dose of PREVNAR on the "appropriate patients. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medication was not reported. In 2013, reported as "a few weeks ago", the patient developed shingles. It was reported that the patient sought unspecified medical attention. The outcome of patient developing shingles a few weeks ago was unknown. Causality was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritus. Diphenhydramine 25 mg PRN.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: This spontaneous report as received from a physician via a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, indication and lot number were not reported). No concomitant medications were reported. On an unknown date, after being administered ZOSTAVAX, the patient experienced rash with pustules. The patient called physician's office. The outcome of rash with pustules was unknown. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of severeal reports from the same source. Additional information is not expected.
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown dates the patient was vaccinated with GARDASIL (route, dose and lot number unknown) doses 1 and 2. The pharmacist reported that the patient received his first 2 doses of GARDASIL on unspecified dates and was due to receive his third dose on an unspecified date approximately one year ago. The patient would like to receive his third dose now. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an Emergency medical technician (E.M.T.) refers to an unspecified number of patients of unknown ages. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (doses, routes, lot numbers and indications were not reported). No concomitant medications were reported. On an unknown date, reported as "starting July 12", GARDASIL was exposed to 31F for a maximum of 15 hours; On an unknown date, reported as 'in August", GARDASIL was exposed to 54F for 15 hours. The reporter stated that there have been additional temperature excursions since then, and patients had received doses of the improperly stored GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age regarding herself. The patient's history of previous pregnancies and live births was not known. The patient became pregnant with an LMP (last menstrual period) of approximately 27-AUG-2012 and an EDD (estimated date of delivery) of approximately 03-JUN-2013. On 17-DEC-2012, the patient was vaccinated with a dose 1 GARDASIL (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. The patient was exposed to GARDASIL during trimester 2. The patient also stated that she would be 16 weeks pregnant on 18-DEC-2012 (reported as tomorrow). The outcome of pregnancy was unknown (outcome pending). All telephone attempts to obtain follow up information has been unsuccessful. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 03-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J001179, expiration date 31-JAN-2015). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013, On 08-OCT-2013, vaccines were discarded, No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 14-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. on 19-SEP-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patients might have been vaccinated with VARIVAX (Merck). Concomitant medications were not reported. The reporter mentioned that VARIVAX (Merck) might have been stored in the refrigerator for an indefinite amount of time. No adverse events were reported. This is one of the several reports of the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patients might have been vaccinated with PROQUAD (Merck). Concomitant medications were not reported. The reporter mentioned that PROQUAD (Merck) might have been stored in the refrigerator for an indefinite amount of time. No adverse events were reported. This is one of the several reports of the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient had no drug reactions/allergies. On 15-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J004599, expiry date: 18-JUL-2014) (dose unspecified) subcutaneous at right arm. Concomitant therapies included with LUNESTA, SOMA, TOPAMAX, enalapril maleate, ZOLOFT, LAMICTAL and BUPAP. Pharmacist reported that the patient developed a red wheal at the injection site after vaccination with ZOSTAVAX. BENADRYL as a treatment was given for the event. The patient had sought medical attention via contacting pharmacist. At the time of report, the outcome of the event was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 26-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 22-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 12-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 17-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 15-AUG-2013, the patients were vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 04-OCT-2013, the patients were vaccinated with a dose of PROQUAD (Merck) (lot #J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood glucose normal, Convulsion, Dizziness, Electrocardiogram normal, Nausea
Clinical narrative: Case number PHHY2013US097420, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: A94886) website on 05 Sep 2013 with the follow-up received from QA department (reference number: 251975) on 17 Oct 2013. This report refers to an 18-year-old female patient. She had no known drug allergies in the past. Concomitant drugs included ZOVIA and Multigen plus. She was vaccinated with MENVEO (batch number: A11046) in the left arm on 21 Jun 2013. On the same date, immediately after vaccination the patient became light headed/dizzy. She then started to seize for less than a minute and emergency service was called. Her blood pressure was 107/85. She was then nauseous. Her blood sugar (96, units not provided), heart rate (22 later 50, units not provided), respiratory rate (16, units not provided) and 12 lead heart tests (normal) were done. It was reported that the patient would see the doctor soon. The outcome of the events was reported as not recovered as of 21 Jun 2013. The seriousness and causality of the events were not reported. Based on the batch review, it was stated that the concerned MENVEO, batch number (A11046) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practice (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 251975) on 12 Sep 2013: Updated QA reference number only. Follow-up received from QA department on 17 Oct 2013: Batch review report updated