chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product reconstitution issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) 0.5 ml approximately in August 2012 "about 1 month ago" because only 0.5 ml could be withdrawn from a vial of ZOSTAVAX following reconstitution with the entire contents of the diluent vial (lot number H013939). No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. PQC is involved. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (id# 746) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 18-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Upper-airway cough syndrome
Clinical narrative: Body aches, sore throat, cough, nasal drip, chills.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Tachycardia, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Erythema, induration, pain at area of vaccinations. Mild fever, tachycardia. Treatment with ibuprofen, ice to area, Benadryl, and narcotic pain medication.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Hypophagia, Malaise
Clinical narrative: Severe nausea and vomiting, general malaise, chills and sweats.  Nausea has continued now for 4 days, haven't been unable to eat much, profound anorexia.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Severe nausea and vomiting, general malaise, chills and sweats.  Nausea has continued now for 4 days, haven't been unable to eat much, profound anorexia.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Autopsy, Death, Musculoskeletal stiffness, Respiratory arrest, Resuscitation
Clinical narrative: Woke up to baby face up, she looked fine, when I went to pick her up she was stiff still warm, but stiff, and not breathing, called 911 paramedics arrived and tried to resuscitate, she had been dead approx 12 mins. Med ex. said it was SIDS. Autopsy report cause of death "undetermined" manner of death: "undetermined, prematurity by history"
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: Woke up to baby face up, she looked fine, when I went to pick her up she was stiff still warm, but stiff, and not breathing, called 911 paramedics arrived and tried to resuscitate, she had been dead approx 12 mins. Med ex. said it was SIDS. Autopsy report cause of death "undetermined" manner of death: "undetermined, prematurity by history"
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: PATIENT COMPLAINS OF SEVERE PAIN IN THIGHS AND LOWER CALFS TO THE POINT WHERE HE IS HAVING DIFFICULTY WALKING. STARTED ON 09/17/2012 AND HAS SUBSIDED SOMEWHAT SINCE THIS REPORT BUT STILL CONTINUES TO HAVE PAIN. HAS A HISTORY OF BLOOD CLOTS SO RECOMMENDED SEEING HIS PHYSICIAN FOR EVALUATION AS SOON AS POSSIBLE.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Dizziness, Flank pain, Pyrexia, Vision blurred
Clinical narrative: Dizziness, fever, chills, blurred vision in left eye. Claims aches and pains only on left side. I advised patient to go to weekend clinic and explain the events.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Hypersensitivity, Vaccination complication
Clinical narrative: Patient received Fluvirin at 10:30 AM, Bled a little more than usual. Nurse applied pressure, and bleeding stopped. Patient returned later and was sent to ER from her physician, Admitted with allergic reaction to flu vaccine.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm between shoulder and elbow that has lasted for almost three years.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Glossodynia, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Sore on underside of tongue. Swelling, hardness, redness radiating out from injection site, fatigue.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Sensation of heaviness
Clinical narrative: Left arm rash 6x3 cm, arm heaviness.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient Fainted shortly after administration of vaccine.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Throat starting feeling itchy. Went to her PCP who prescribed a Medrol Dose Pack.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Tremor
Clinical narrative: PATIENT COMPLAINED OF  HIGH FEVER/ TREMORS AND LOCAL INJECTION SITE WARTH AND ERYTHEMA.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Cold sweat, Dizziness, Feeling abnormal
Clinical narrative: At approximately 5:30 PM, my daughter complained of headache. 10 minutes later she said, she felt like she was going to vomit. She became clammy, collapsed a bit on the couch. At 6:15 her temperature was checked and after seeing that her temperature was 103 degrees fahrenheit, I walked her to her room and layed her down in bed. I administered motrin and a cold pack to her forehead. I stayed with her in her bedroom. about 7:30, her fever had not reduced at all. I gave her a cold bath, and 30 minutes later, it dropped to 100 degrees fahrenheit. She complained of stomach ache, weakness, she said she felt like her mind/body was trying to shut down. She also said she felt like she was going to faint/and die. I stayed with her for 3 hours and checked on her hourly until the next morning, when her fever subsided. She was weak and lethargic for 2 days afterward, and her color was very pale and clammy looking.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Lethargy, Nausea, Pallor, Pyrexia
Clinical narrative: At approximately 5:30 PM, my daughter complained of headache. 10 minutes later she said, she felt like she was going to vomit. She became clammy, collapsed a bit on the couch. At 6:15 her temperature was checked and after seeing that her temperature was 103 degrees fahrenheit, I walked her to her room and layed her down in bed. I administered motrin and a cold pack to her forehead. I stayed with her in her bedroom. about 7:30, her fever had not reduced at all. I gave her a cold bath, and 30 minutes later, it dropped to 100 degrees fahrenheit. She complained of stomach ache, weakness, she said she felt like her mind/body was trying to shut down. She also said she felt like she was going to faint/and die. I stayed with her for 3 hours and checked on her hourly until the next morning, when her fever subsided. She was weak and lethargic for 2 days afterward, and her color was very pale and clammy looking.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Injection site mass, Syncope, Visual impairment
Clinical narrative: See attached page. On 09/19/2012 patient received inactivated INFLUENZA vaccine and developed a hard lump at the injection site immediately after vaccination into left deltoid. Patient was instructed to sit and wait for 15-20 minutes for observation and to make sure no further reaction developed. Upon walking to waiting area, patient became light-headed and wanted to lie down. As she was being helped to bench where she could lay down, patient fainted. We laid her down on the floor and elevated her legs. Patient was given ammonia salts and blood pressure was taken (116/83, pulse 64). Patient was alert and responsive throughout this whole time. Patient was then given water and stated that she was feeling better and wanted to attempt to sit up. Upon sitting, patient stated she began to feel light-headed again. Her blood pressure was taken at this time and it was 93/65, pulse 66. Patient was instructed to lie down again and legs were elevated. A co-worker grabbed a bag of Fritos to give to patient to try to bring her blood pressure (something salty). Patient continued to eat and drink while lying down and blood pressure was taken again (118/84, pulse 65). Patient then wanted to try to sit up again. After a few minutes of sitting, blood pressure was taken and it was 84/57, pule 66. At this time, patient reported seeing spots in her vision. She related this to how she felt she felt sometimes when she had atypical migraines (aura). Patient's blood pressure was again taken while sitting and it was 95/74, pulse 67, so she was laid back down again. When it became apparent that patient's blood pressure was not holding upon sitting EMS was called. By the time they arrived approximately 45 minutes had elapsed since the injection and approximately 30 minutes since patient had fainted. EMS spoke to the patient, took her blood pressure, and found it holding around 100/75. Patient reported feeling much better and no longer seeing spots. She was released into her husband's care and went home. We attempted to reach the patient to check on her status in the afternoon on 09/19 without success. A second attempt to reach the patient was made on 09/21 and was successful. Patient reports feeling much better with no residual or returning symptoms. The patient called her doctor and informed him of the episode but has not received any additional instructions. She reports being thankful that we were attentive and helpful during the episode and the she ultimately is feeling better and did not require hospitalize. Her only concern was whether or not she will need revaccination. We informed the patient that this episode should not affect her immune response to the vaccine.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: After 2 days 9/15/12 after school, had rash on knees, inner thigh & lower back (size of oatmeal grain) & small rash over all body. Pt went to the MD 9/17/12 MD confirm possible reaction on vaccine. Pt if followed up by MD right now, given prednisone.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site rash, Malaise
Clinical narrative: Pt states feels unwell red rash spread from injection site to upper arm - very painful - Had RN look at & mark developed next day & progressed looks to be bruised as well. Going to family dr next day as advised by Rph.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 24 days old patient who on 21-JUN-2012, was vaccinated with a 2 ml dose of ROTATEQ (lot number not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site haematoma
Clinical narrative: This spontaneous report as received from a doctor's nurse via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported). It was reported that the patient experienced injection site reactions after getting ZOSTAVAX. The patient had a red area, around the diameter of a tennis ball that started within 24 hours of the injection and lasted 10-12 days. He also experienced discomfort at the site that lasted about 3-5 days, and there was bruising that lasted for an unspecified length of time. The patient sought for unspecified medical attention. No treatment was given. On an unspecified date the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported). It was reported that someone the physician came into contact with, developed chicken pox. It was unspecified whether the patient sought for medical attention. The outcome of chicken pox was unknown. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 36 years old female patient. The patient had no pertinent medical history. The patient had no known drug allergies. On 17-SEP-2012 the patient was vaccinated by the pharmacist with 0.65 ml ZOSTAVAX (lot # 673029/0616AE, expiration date 28-JUN-2013) subcutaneously in back of left upper arm. Concomitant medications were reported as none. It was reported that the patient experienced injection site reaction of red, itchy, and swelling the size of a silver dollar. The patient sought for medical attention by sending a photo showing the injection site reaction through smart phone to the pharmacist on 18-SEP-2012. No treatment was given. The outcome was reported as not recovered. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to a 68 years old male patient with asthma, diabetes, hypertension and hyperlipidemia. The patient's medical history included anemia. The patient had none drug allergies. On 17-SEP-2012 the patient was vaccinated with a single dose of ZOSTAVAX (lot # 673029/0616AE, expiration date 28-JUN-2013) subcutaneously. Concomitant medications included multiple unspecified medications. On 18-SEP-2012 the patient developed lesions on one side of his chest and back. The patient sought for medical attention by coming to the office on 18-SEP-2012 and was diagnosed with shingles. Lab diagnostics studies performed were reported as none. The outcome of shingles was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a doctor's nurse via a company representative refers to a non-pregnant female patient of unknown age. On an unknown date the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported). It was reported that the patient experienced injection site reactions after getting ZOSTAVAX. The patient's adverse event started within 24 hours of the injection. Her reaction was "warm, red and hard" and was the size of an egg. The adverse event lasted 10-12 days. The patient sought for unspecified medical attention. As a treatment, she was advised to alternate between warm and cold compresses. No rash was involved with the patient. On an unspecified date the patient was recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Eye discharge, Feeling cold, Immobile, Pyrexia
Clinical narrative: MUCUS POURING OUT OF EYES, 102' FEVER, EXTREMELY COLD, IMMOBILE.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Influenza, Malaise, Maternal exposure during pregnancy, Oropharyngeal pain
Clinical narrative: SORE THROAT, RUNNY NOSE, SNEEZING, HEADCAHE, FEVER, BODYACHE, SINUS PRESSURE, GENERALIZED MALAISE (got flu within 24 hours of getting Flu shot, spread it to other family members, resulted in unnecessary use of meds during first trimester of pregnancy).
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Rhinorrhoea, Sinus headache, Sneezing
Clinical narrative: SORE THROAT, RUNNY NOSE, SNEEZING, HEADCAHE, FEVER, BODYACHE, SINUS PRESSURE, GENERALIZED MALAISE (got flu within 24 hours of getting Flu shot, spread it to other family members, resulted in unnecessary use of meds during first trimester of pregnancy).
Age: 56.0
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Pyrexia
Clinical narrative: Fever to 103.3. Lasted <12h.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Flushing, Headache, Injection site erythema, Injection site haematoma
Clinical narrative: Woke up flushed and complaining of headache. By 3:30 pm (after attending preschool) he was much more flushed looking and hot to the touch - temperature taken rectally and was 101. The site of shot was slightly red and warm to touch as well. By the following day, 9/22/2012 temperature was down to 99 degrees, but the injection site was extremely bruised, very red and swollen and hot to touch (bruise length approx 2 inches long, red and swollen part approx 7 inches diameter).
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Woke up flushed and complaining of headache. By 3:30 pm (after attending preschool) he was much more flushed looking and hot to the touch - temperature taken rectally and was 101. The site of shot was slightly red and warm to touch as well. By the following day, 9/22/2012 temperature was down to 99 degrees, but the injection site was extremely bruised, very red and swollen and hot to touch (bruise length approx 2 inches long, red and swollen part approx 7 inches diameter).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Pyrexia, Swollen tongue
Clinical narrative: Injection site redness and hardness later that day on the 15th. Night of the 15th had swelling at the back of tongue. Next day (16th) midafternoon she was extremely tired and had a low grade fever. On 9/22 patient still had injection site redness.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Rash
Clinical narrative: Rash on Neck. Fatigue. Shortness of Breath.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Heart rate increased
Clinical narrative: DIZZY WHEN GETTING UP AND DOWN OR LOOKING UP AND DOWN, ALSO FAST HEART RATE - NOTICED WHEN EXERCISING IN AM - LASTED ALL DAY AT WORK - AT NIGHT DIZZINESS IN BED AND FAST HEART RATE - STILL SOME NEXT AM, BUT BETTER AS DAY WENT ON - COMPLETELY GONE BY NIGHT OF 9/18- NO DIZZINESS OR FAST HEART RATE IN BED THAT NIGH   THIS DID NOT HAPPEN LAST YEAR W/FLU SHOT.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Lethargy, Pain
Clinical narrative: 1 day Fever 101.4. Body aches, lethargy, headache. 5 day Diarrhea. Treatments Ibuprofen for fever and nothing for intestinal discomfort.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: 1 day Fever 101.4. Body aches, lethargy, headache. 5 day Diarrhea. Treatments Ibuprofen for fever and nothing for intestinal discomfort.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Mobility decreased, Urticaria
Clinical narrative: The day after the vaccine she experienced arm immobility, difficulty breathing, and urticaria spreading across her entire upper arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Arm at site of injection is described as a hard welt, size of about a silver dollar pancake. Very hot to touch.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Injection site pain, Mobility decreased
Clinical narrative: Extensive chills, injection site extremely sore. Complete body weakness, Muscles sore from tips of fingers thru end of toes. (Legs, arms etc). Nausea, light headed and feeling faint. Couldn't get up off chair or couch with help.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea
Clinical narrative: Extensive chills, injection site extremely sore. Complete body weakness, Muscles sore from tips of fingers thru end of toes. (Legs, arms etc). Nausea, light headed and feeling faint. Couldn't get up off chair or couch with help.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: VACCINE GIVEN AT 03:00PM AND PT RETUNRED TO PHARMACY STATING SHE HAD SWELLING IN HER HAND. GAVE THE PT THE OPTION ON BENADRYL AND RECCOMMENDED F/U AT URGENT CARE.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient reported developing large rash at inject site after administration of the flu vaccine. 4 days had passed and rash has not cleared.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient reported developing large rash at inject site after administration of the flu vaccine. 4 days had passed and rash has not cleared.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm red, swollen, and hot to touch. Red spot is about as big as a tennis ball.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe headache, nausea and vomiting, loose stools; injection site is sore, red, hot, and swollen.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Nausea, Vomiting
Clinical narrative: Severe headache, nausea and vomiting, loose stools; injection site is sore, red, hot, and swollen.
Age: 30.0
Sex: M
Vaccine: ANTH, FLUN3, HEP, SMALL, TYP
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Noticed rash on both forearms that would/did flare up and down: Atarax. 9/21/12 early am pain hands and noticed on bump on R elbow: Benadryl. 9/22/12 after 7pm, 30+ bumps on L&R arms and hands that itch and are raised; Claritin. 9/22/12 approx 11:30 am bumps moved toward both knees.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Middle to night after admin. woke up with severe hives/welts on legs/torso.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased
Clinical narrative: Patient complained of pain at site of injection. Could not move her (left) arm and get out of bed. Still hurting at site of injection. No swelling observed on 9/23/12. Cannot move her left arm beyond a certain height.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient returned to pharmacy 9-10-12 with a hard, hot-to-the-touch, red reaction at injection site. Red erythema had spread to 24" diameter across arm.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to pharmacy 9-10-12 with a hard, hot-to-the-touch, red reaction at injection site. Red erythema had spread to 24" diameter across arm.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient returned to pharmacy 9-10-12 with a hard, red, hot to the touch, reaction at the injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient returned to pharmacy 9-10-12 with a hard, red, hot to the touch, reaction at the injection site.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient called 2 days after vaccine concerned about redness, swelling & knot at injection site. Redness was about 3 inches in diameter - felt small knot suggested treat w/ ice & anti-inflammatory.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: Patient called 2 days after receiving vaccine. Concerned about redness, swelling, knot at injection site. Also had low grade fever. Redness about 3" diameter - small know. Suggested ice & anti inflammatory.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Slight swelling, redness, pain to touch (no itching) in the upper arm and around the arm (upper arm).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Migraine
Clinical narrative: Patient complained of bad migraine-like headache for 3 days after administration of vaccine. Also developed 2 spots in the body red around & brown inside.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal pain
Clinical narrative: Patient came to pharmacy on 9/15/12 to show us her right arm where she had received ZOSTAVAX. Her arm was red around injection site 2" diameter area. Complained of ache in RT. shoulder.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: Pt came in an 9/23/12 and complained that there is discoloration at the site of injection as well as some redness/itching.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Malaise, White blood cell count decreased
Clinical narrative: Could not stand, sick, hospital had  WBC 1.0.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Malaise, White blood cell count increased
Clinical narrative: Sick, very weak - hospital visit. WBC = 25.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (dose, route, lot # unknown) on 16-JUL-2010 and the second dose of GARDASIL (dose, route, lot # unknown) late on 23-NOV-2011. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a company representative via physician refers to a 4 months old patient. On an unknown date, 4 months old patient received first dose of ROTATEQ. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse event reported. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old male patient. The patient was intramuscularly vaccinated with second dose of PNEUMOVAX23 (lot #672962/0025AE, dose/frequency unspecified) on 14-SEP-2012. It was reported that the patient received PNEUMOVAX23 on 14-SEP-2012 and later developed "a fever, chills, redness, warmth and soreness below the site where PNEUMOVAX23 was administered". The pharmacist also mentioned the patient received PNEUMOVAX23 on an unspecified date 5 years ago (??-SEP-2012) prior to received the vaccine on 14-SEP-2012. The patient had sought medical attention via contacting pharmacy. No lab diagnostics studies performed and no treatment was given for the adverse events. The outcome of all adverse events was reported as not recovered/not resolved. Additional information is not expected.
Age: 0.02
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# 666186/1483Y, Expiration Date: 10-SEP-2012) intramuscular on 13-SEP-2012. The reporting nurse noted this was the first dose in the RECOMBIVAX HB vaccination series for this patient. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV2, VARCEL, HPV2, VARCEL
Symptoms: Fatigue, Influenza like illness, Nausea, Oedema peripheral, Pain
Clinical narrative: This spontaneous report as received from GlaxoSmithKline and was assigned manufacturer report number A0991830A for CERVARIX, refers to a 14 years old female patient with no known allergies. The patient was vaccinated with dose 2 VARIVAX (Merck) (lot#1295AA) on 14-MAY-2012 16:30. Concomitant medications included CERVARIX (lot # AHPVA113BB) (0.5 ml) on the same day at the same time. On 14-MAY-2012, about one hour after vaccination at 17:30, the patient experienced flu like symptoms, fatigue, swelling arm, overall body pain, and nausea. The relatedness for adverse events was unknown for VARIVAX (Merck). The physician considered the events were disabling. The event last for 3 days. On 17-MAY-2012, the events were resolved. The subject consulted her healthcare provider. The vaccination course with CERVARIX was discontinued. The original reporter was a physician. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Induration, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a currently 72 years old female patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011335, expiration date 08-SEP-2013) SQ on 13-SEP-2012. No other co-suspects were reported. Concomitant medications were not reported and were considered as "nothing that should be a problem". The pharmacist reported that on 15-SEP-2012, the patient experienced at the site injection there was a lump, swelling, pain, redness, itching and warmth. In the opposite arm, where the vaccine was not administered, the patient noted pain and that the arm felt funny. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Sensory disturbance
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a currently 72 years old female patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011335, expiration date 08-SEP-2013) SQ on 13-SEP-2012. No other co-suspects were reported. Concomitant medications were not reported and were considered as "nothing that should be a problem". The pharmacist reported that on 15-SEP-2012, the patient experienced at the site injection there was a lump, swelling, pain, redness, itching and warmth. In the opposite arm, where the vaccine was not administered, the patient noted pain and that the arm felt funny. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a currently 72 years old female patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011335, expiration date 08-SEP-2013) SQ on 13-SEP-2012. No other co-suspects were reported. Concomitant medications were not reported and were considered as "nothing that should be a problem". The pharmacist reported that on 15-SEP-2012, the patient experienced at the site injection there was a lump, swelling, pain, redness, itching and warmth. In the opposite arm, where the vaccine was not administered, the patient noted pain and that the arm felt funny. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a currently 72 years old female patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011335, expiration date 08-SEP-2013) SQ on 13-SEP-2012. No other co-suspects were reported. Concomitant medications were not reported and were considered as "nothing that should be a problem". The pharmacist reported that on 15-SEP-2012, the patient experienced at the site injection there was a lump, swelling, pain, redness, itching and warmth. In the opposite arm, where the vaccine was not administered, the patient noted pain and that the arm felt funny. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Cellulitis
Clinical narrative: Cellulitis - admitted 9/9/12 - 9/11/12, received IV clindamycin.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Call from friend 9/17/12. Reports patient complaint today of LA soreness last night. Now (approximately 12 noon) arm red, hot from site of injection down approximately 5" and half way around arm. Advised to call MD as it was so long after injection and see MD, apply cool compress. 9/18/12 to hospital, dx cellulitis.
Sex: F
Vaccine: HPV4
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: This spontaneous report as received from a physician refers to a female teenaged patient. The physician stated that he received an e-mail from a colleague that said a "Teenaged female patient was hospitalized at a hospital, with acute disseminated encephalomyelitis (which started in August 2012, "within last month") two weeks after she received an injection of GARDASIL (0.5 ml, intramuscularly, Lot# unspecified). The patient had sought unspecified medical attention. The outcome was unknown. Acute disseminated encephalomyelitis was considered to be life-threatening by reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Toxicologic test
Clinical narrative: Patient seen in office for well child check, normal healthy child with viral symptoms. Immunizations performed, child tolerated well. Following morning found deceased.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid red, swollen & warm to touch. Also with firmness. Ibuprofen 300mg was given at 9:20AM, and applied ice to site. Erythema and firmness is on anterior upper arm extending over half the upper arm. Nothing posteriorly.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Death
Clinical narrative: Initial report was received from a health care professional on 12 September 2012. A 24-year-old female patient received dose one of an intramuscular injection of ("the rabies series") IMOVAX Rabies, sanofi pasteur SA, H1091-1 (indication and site and side of administration were not reported) on 11 September 2012. According to reporter, the patient did not have any reactions when she went home. The next day, it was reported that the client died during the night. Exact date of death was reported as unknown, either 11 September 2012 or 12 September 2012, as reported "during the night". The medical examiner was called to verify the death, and details were not available at the time of the report. No information was reported at this time on if an autopsy was performed. The patient's outcome was fatal. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Anti-SS-A antibody negative, Anti-SS-B antibody negative, Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody, Antinuclear antibody positive
Clinical narrative: Initial case was retrieved from a search of the scientific literature on 10 September 2012. The following is verbatim from the article: "A 33-year-old female with no significant past medical history was referred to the rheumatology clinic in May 2010 by her primary care physician for having pain and swelling in multiple joints since November 2009. Patient received a seasonal flu shot in October and a week later, she noted some joint pain and aches in hands, wrists, and knees, which resolved within a few days and patient became asymptomatic. A month later, she received H1N1 vaccine and a week after started experiencing joint pain, swelling, and stiffness in hand, wrist, elbow, shoulder, and knee joints. She also complained of significant morning stiffness that last for more than one hour. On physical examination she had bilateral synovitis in fourth and fifth metacarpophalangeal (MCP), second, and third proximal interphalangeal (PIP) joints, with prominent left ulnar styloid. She fulfilled most of the criteria for classification of RA based on College of Rheumatology (CR) guidelines. Laboratory findings initially included an erythrocyte sedimentation rate (ESR) of 24 mm/hr, rheumatoid factor (RF) of 26 IU/mL, C-reactive protein (CRP) of 1.3mg/dL, cyclic citrullinated peptide (CCP) IgG of 212. Her basic chemistry, liver function tests, hemoglobin, and complement levels were essentially within normal limits. Serological tests were positive for antinuclear antibody (ANA), RF, anticyclic citrullinated peptide (anti-CCP) and negative for SSA, SSB, hepatitis C virus, parvovirus B19 and being immunized for hepatitis B. Her radiological findings were negative for any joint effusion or destruction. On initial presentation to her PCP, she was given a 10-day course of prednisone 40mg daily, which partially helped with symptoms in the beginning with eventual relapse of symptoms. Later she was started on methotrexate 7.5 mg weekly along with a short duration (3 weeks) of low-dose prednisone with daily folic acid and calcium/vitamin D supplementation. During her follow-up visit about 2 months later, her disease activity score (DAS) were 4.83 and number of tender joints was 7 and number of swollen joints were 5, with significant improvement in morning stiffness which lasted for 5-10 minutes. However, her pain was controlled only while she was on steroid therapy for 3 weeks and had returned thereafter. Later she was switched to golimumab (TNF-a inhibitor) 50mg once monthly subcutaneously. Her methotrexate dose was also increased to 12.5mg weekly. At her third visit her symptoms were much improved and her ESR and CRP were also within normal limits. In conclusion, a causal relationship has not been confirmed between swine-flu vaccine and onset of RA, but there is a temporal connection between the two based on our case report." The patient's outcome was not reported. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, C-reactive protein increased, Complement factor normal, Haemoglobin normal, Hepatitis C test negative
Clinical narrative: Initial case was retrieved from a search of the scientific literature on 10 September 2012. The following is verbatim from the article: "A 33-year-old female with no significant past medical history was referred to the rheumatology clinic in May 2010 by her primary care physician for having pain and swelling in multiple joints since November 2009. Patient received a seasonal flu shot in October and a week later, she noted some joint pain and aches in hands, wrists, and knees, which resolved within a few days and patient became asymptomatic. A month later, she received H1N1 vaccine and a week after started experiencing joint pain, swelling, and stiffness in hand, wrist, elbow, shoulder, and knee joints. She also complained of significant morning stiffness that last for more than one hour. On physical examination she had bilateral synovitis in fourth and fifth metacarpophalangeal (MCP), second, and third proximal interphalangeal (PIP) joints, with prominent left ulnar styloid. She fulfilled most of the criteria for classification of RA based on College of Rheumatology (CR) guidelines. Laboratory findings initially included an erythrocyte sedimentation rate (ESR) of 24 mm/hr, rheumatoid factor (RF) of 26 IU/mL, C-reactive protein (CRP) of 1.3mg/dL, cyclic citrullinated peptide (CCP) IgG of 212. Her basic chemistry, liver function tests, hemoglobin, and complement levels were essentially within normal limits. Serological tests were positive for antinuclear antibody (ANA), RF, anticyclic citrullinated peptide (anti-CCP) and negative for SSA, SSB, hepatitis C virus, parvovirus B19 and being immunized for hepatitis B. Her radiological findings were negative for any joint effusion or destruction. On initial presentation to her PCP, she was given a 10-day course of prednisone 40mg daily, which partially helped with symptoms in the beginning with eventual relapse of symptoms. Later she was started on methotrexate 7.5 mg weekly along with a short duration (3 weeks) of low-dose prednisone with daily folic acid and calcium/vitamin D supplementation. During her follow-up visit about 2 months later, her disease activity score (DAS) were 4.83 and number of tender joints was 7 and number of swollen joints were 5, with significant improvement in morning stiffness which lasted for 5-10 minutes. However, her pain was controlled only while she was on steroid therapy for 3 weeks and had returned thereafter. Later she was switched to golimumab (TNF-a inhibitor) 50mg once monthly subcutaneously. Her methotrexate dose was also increased to 12.5mg weekly. At her third visit her symptoms were much improved and her ESR and CRP were also within normal limits. In conclusion, a causal relationship has not been confirmed between swine-flu vaccine and onset of RA, but there is a temporal connection between the two based on our case report." The patient's outcome was not reported. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Joint stiffness, Joint swelling, Laboratory test normal, Liver function test normal, Musculoskeletal stiffness
Clinical narrative: Initial case was retrieved from a search of the scientific literature on 10 September 2012. The following is verbatim from the article: "A 33-year-old female with no significant past medical history was referred to the rheumatology clinic in May 2010 by her primary care physician for having pain and swelling in multiple joints since November 2009. Patient received a seasonal flu shot in October and a week later, she noted some joint pain and aches in hands, wrists, and knees, which resolved within a few days and patient became asymptomatic. A month later, she received H1N1 vaccine and a week after started experiencing joint pain, swelling, and stiffness in hand, wrist, elbow, shoulder, and knee joints. She also complained of significant morning stiffness that last for more than one hour. On physical examination she had bilateral synovitis in fourth and fifth metacarpophalangeal (MCP), second, and third proximal interphalangeal (PIP) joints, with prominent left ulnar styloid. She fulfilled most of the criteria for classification of RA based on College of Rheumatology (CR) guidelines. Laboratory findings initially included an erythrocyte sedimentation rate (ESR) of 24 mm/hr, rheumatoid factor (RF) of 26 IU/mL, C-reactive protein (CRP) of 1.3mg/dL, cyclic citrullinated peptide (CCP) IgG of 212. Her basic chemistry, liver function tests, hemoglobin, and complement levels were essentially within normal limits. Serological tests were positive for antinuclear antibody (ANA), RF, anticyclic citrullinated peptide (anti-CCP) and negative for SSA, SSB, hepatitis C virus, parvovirus B19 and being immunized for hepatitis B. Her radiological findings were negative for any joint effusion or destruction. On initial presentation to her PCP, she was given a 10-day course of prednisone 40mg daily, which partially helped with symptoms in the beginning with eventual relapse of symptoms. Later she was started on methotrexate 7.5 mg weekly along with a short duration (3 weeks) of low-dose prednisone with daily folic acid and calcium/vitamin D supplementation. During her follow-up visit about 2 months later, her disease activity score (DAS) were 4.83 and number of tender joints was 7 and number of swollen joints were 5, with significant improvement in morning stiffness which lasted for 5-10 minutes. However, her pain was controlled only while she was on steroid therapy for 3 weeks and had returned thereafter. Later she was switched to golimumab (TNF-a inhibitor) 50mg once monthly subcutaneously. Her methotrexate dose was also increased to 12.5mg weekly. At her third visit her symptoms were much improved and her ESR and CRP were also within normal limits. In conclusion, a causal relationship has not been confirmed between swine-flu vaccine and onset of RA, but there is a temporal connection between the two based on our case report." The patient's outcome was not reported. Documents held by sender: None.