chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age is also the patient. Patient's concurrent conditions included contact dermatitis. On an unknown date the patient was vaccinated with a dose of hepatitis A vaccine (manufacturer unknown) (dose, route, lot# and expiration date were not reported). On an unknown date the patient experienced swelling at the injection site. The outcome of the event was reported as recovered/resolved (date unknown). Relatedness between the event and hepatitis A vaccine (manufacturer unknown) was not provided. This case is linked to MARRS# 1410USA014200 (same patient link). Additional information has been requested.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age who is also the patient. Patient's concurrent conditions included contact dermatitis. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On an unknown date the patient experienced redness and swelling at the injection site. The outcome of the events was reported as recovered/resolved (date unknown). Relatedness between the events and ZOSTAVAX was not provided. This case is linked to MARRS# 1410USA016617 (same patient link). Additional information has been requested.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age who is also the patient. Patient's concurrent conditions included contact dermatitis. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On an unknown date the patient experienced redness and swelling at the injection site. The outcome of the events was reported as recovered/resolved (date unknown). Relatedness between the events and ZOSTAVAX was not provided. This case is linked to MARRS# 1410USA016617 (same patient link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 26-OCT-2014 to 29-OCT-2014, the patients were vaccinated with M-M-R II (dose, lot number and frequency were not reported), subcutaneous for an unknown indication. Concomitant medications were not reported. The patients received M-M-R II that was improperly stored. On an unknown date, M-M-R II was exposed to 11.1 Celsius for 1 hour 18 minutes (all doses supported). No adverse effects reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from Medical Assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date in 2014 the patients were vaccinated with PROQUAD (dose, route of administration and indication were not provided). It was reported that the patients received doses of PROQUAD that underwent supported temperature excursions. Doses were administered between the dates of 26-AUG-2014 through 29-OCT-2014. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 27-OCT-2014 the patient was vaccinated with a third dose of GARDASIL (dose, route, lot# and expiration date not reported). Physician reported that the patient received his first dose of GARDASIL on 17-OCT-2013 and the second dose on 31-JAN-2014. No adverse experience reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site discolouration, Injection site rash, Injection site swelling
Clinical narrative: Parent reports pt. had swelling of arm at site of HPV injection, then developed hypopigmented spots in same area that are not resolving (8 mm diameter rash).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, current conditions, concomitant medications, drug reactions and allergies were not reported. On 23-OCT-2014 the patient was inadvertently vaccinated with M-M-R II (dose, route of administration, anatomical location and lot # were reported) which had expired on 20-SEP-2014. On the same day the patient was also inadvertently vaccinated with VARIVAX (Merck) (dose, route of administration, anatomical location and lot # were not reported) which had expired on 15-OCT-2014. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Medical Assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date in 2014 the patients were vaccinated with VARIVAX (dose, route of administration and indication were not provided). It was reported that the patients received doses of VARIVAX that underwent supported temperature excursions. Doses were administered between the dates of 26-AUG-2014 through 29-OCT-2014. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Medical Assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date in 2014 the patients were vaccinated with ZOSTAVAX (dose, route and administration and indication were not provided). It was reported that the patients received doses of ZOSTAVAX that underwent supported temperature excursions. Doses were administered between the dates of 26-AUG-2014 through 29-OCT-2014. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Rash
Clinical narrative: Pt was given Varicella and MMR on 10/27/14. On 10/28/14, she returned to clinic with a rash on abdomen/back/face. Mild redness at vaccine site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 26-OCT-2014 to 29-OCT-2014, the patients were vaccinated with GARDASIL (dose, lot number and frequency were not reported), intramuscular. Concomitant medications were not reported. The patients received GARDASIL that was improperly stored. On an unknown date, GARDASIL was exposed to 11.1 Celsius for 1 hour 18 minutes (all doses supported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia
Clinical narrative: Following receiving the flu shot in my left upper arm, my pinky finger became numb and has been numb ever since as well as the part of my hand below the pinky finger.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Following receiving the flu shot in my left upper arm, my pinky finger became numb and has been numb ever since as well as the part of my hand below the pinky finger.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Heart rate increased, Local swelling, Musculoskeletal pain, Oropharyngeal pain
Clinical narrative: I had shot Tuesday evening at 1:22 PM. By 6:00 PM I had pain that became more severe as the nite went on. By 8:00 PM, pain in left arm reaching down arm to fingers.  Radiating into shoulder area to throat. Slight swelling on left side of neck.  Also some rapid heart beats.  Pain lasted through Thursday morning to a soreness in joint where should joins arm. Any pressure on should would cause pain to radiate down to elbow with stringing feeling. (Pain on a scale of 1-10) was at times very severe, being a 9 or 10. Ice pack, Excedrin or pain patches didn't help.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: I had shot Tuesday evening at 1:22 PM. By 6:00 PM I had pain that became more severe as the nite went on. By 8:00 PM, pain in left arm reaching down arm to fingers.  Radiating into shoulder area to throat. Slight swelling on left side of neck.  Also some rapid heart beats.  Pain lasted through Thursday morning to a soreness in joint where should joins arm. Any pressure on should would cause pain to radiate down to elbow with stringing feeling. (Pain on a scale of 1-10) was at times very severe, being a 9 or 10. Ice pack, Excedrin or pain patches didn't help.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Rash at neck and lower back. It appears onset of shingles, varicella type symptoms.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Computerised tomogram, Convulsion, Electrocardiogram, Eye movement disorder
Clinical narrative: Immediately following the injection, my daughter began exhibiting seizure like symptoms. For several seconds, she was convulsing and her eye movement was erratic. Her blood pressure dropped and she was sweating.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Hyperhidrosis, Immediate post-injection reaction, Seizure like phenomena
Clinical narrative: Immediately following the injection, my daughter began exhibiting seizure like symptoms. For several seconds, she was convulsing and her eye movement was erratic. Her blood pressure dropped and she was sweating.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Lacrimation increased, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Patient's mother reported child had symptoms of itching on 10/18/14 in the evening, red rash started on toes, then feet on 10/19/14, rash seen on hands next with swelling, during the week progressed to back, arms and legs; rash did not appear on face, chest or neck; mild cough, watery eyes; mother treated with cortisone ointment and Benadryl at home, did not go to MD or clinic.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Swelling
Clinical narrative: Patient's mother reported child had symptoms of itching on 10/18/14 in the evening, red rash started on toes, then feet on 10/19/14, rash seen on hands next with swelling, during the week progressed to back, arms and legs; rash did not appear on face, chest or neck; mild cough, watery eyes; mother treated with cortisone ointment and Benadryl at home, did not go to MD or clinic.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain upper, Fatigue, Nausea, Pain
Clinical narrative: Nausea, stomach pain/bloating, fatigue, body aches.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Lip blister
Clinical narrative: Blisters top lip....husband also had same reaction day earlier.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Insomnia, Myalgia
Clinical narrative: Muscle pain, joint pain, redness & swelling @ injection site, "overwhelmed by pain", unable to sleep.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Muscle pain, joint pain, redness & swelling @ injection site, "overwhelmed by pain", unable to sleep.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Myalgia
Clinical narrative: Extreme chills & aching muscles - shoulders back and legs. Felt faint and light headed. Talked to Physician who encouraged me to take Benadryl (50mg).
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Malaise, Muscle spasms, Nausea, Urticaria
Clinical narrative: Gardasil vaccine - Nausea, diarrhea, cramping, severe case of hives lasting several days, malaise. Patient is frequently getting hives to this day. Patient had never had hives prior to vaccination reaction.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Hyperhidrosis, Injection site discolouration, Injection site erythema, Injection site reaction
Clinical narrative: Sweating and severe diarrhea.  Arm where shot was administered developed a red welp size of half dollar and stayed for over a week and then turned brown.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Sweating and severe diarrhea.  Arm where shot was administered developed a red welp size of half dollar and stayed for over a week and then turned brown.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Injection site erythema, Injection site reaction, Malaise
Clinical narrative: Fever (100.8) and malaise, nasal congestion, muscle aches, joint pain, cough, 24 hours. Red, blotchy patch near -- but not on -- the injection site, appeared after 24 hours and remained another 24 hours.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nasal congestion, Pyrexia, Rash macular
Clinical narrative: Fever (100.8) and malaise, nasal congestion, muscle aches, joint pain, cough, 24 hours. Red, blotchy patch near -- but not on -- the injection site, appeared after 24 hours and remained another 24 hours.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Site of injection (subcutaneous) on back of upper arm become very sore, swollen, and red.  Over the next five days the soreness, swelling, and redness traveled further done my arm each day, all the way to mid lower arm, when it finally dissipated.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Site of injection (subcutaneous) on back of upper arm become very sore, swollen, and red.  Over the next five days the soreness, swelling, and redness traveled further done my arm each day, all the way to mid lower arm, when it finally dissipated.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Hyperhidrosis, Nasal congestion, Pharyngeal oedema, Throat irritation
Clinical narrative: Swollen throat, itchy throat, nasal congestion, chills, sweats.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site bruising, Injection site pain, Insomnia
Clinical narrative: Severe pain to injection site at upper left arm. Injection administered very, very high on the arm. Pain increasing with intensity over the next few days. Bruising at site present withing a few days. Restricted range of motion of left arm. Unable to lift my arm due to severe pain. Pain increases at night and sleeping is hampered due to pain.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Burning sensation, Bursitis, Drug administered at inappropriate site, Injection site pain
Clinical narrative: Injection was given into the bursa of my left shoulder. The injection was given too high and was very painful, causing burning in my shoulder and all the way down my arm and into my hand.  The following days since, I have constant pain that wakes me up at night and the pain is severe with certain movements, restricting my range of motion.  I saw dr. and he diagnosed me with bursitis.  I have been told to take anti inflammatories as needed and that if things don't improve, I can get a steroid injection.  This has really affected my work and home life, seeing that I am a bedside nurse and a mother of two young and active children.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Middle insomnia, Pain
Clinical narrative: Injection was given into the bursa of my left shoulder. The injection was given too high and was very painful, causing burning in my shoulder and all the way down my arm and into my hand.  The following days since, I have constant pain that wakes me up at night and the pain is severe with certain movements, restricting my range of motion.  I saw dr. and he diagnosed me with bursitis.  I have been told to take anti inflammatories as needed and that if things don't improve, I can get a steroid injection.  This has really affected my work and home life, seeing that I am a bedside nurse and a mother of two young and active children.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Oedema, Swelling
Clinical narrative: Patient experienced fairly extensive swelling (she first notified me at ~4:30 PM on 10/31/14) that I would say ~ +2 edema (no pitting noted). She also noted the injection site to be red and slightly painful. She said it was worse the day(s) before, but it was much better.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Oropharyngeal pain
Clinical narrative: FATIGUE, SORE THROAT, REDNESS AT INJECTION SITE-ABOUT THE SIZE OF YOUR PALM.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted right after Fluzone Quadrivalent was given.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Patient alleges vaccine administered too high and now patient is suffering from pain and disomfort in shoulder that has not subsided in over a month despite over the counter remedies. Patient f/u with PCP for evaluation.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Discomfort, Insomnia, Pyrexia
Clinical narrative: Insomnia despite taking sleeping medication (I was unable to sleep the entire night, which does not happen to me), severe stomach pains, discomfort of torso, fever.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient had been vomiting all afternoon since returning home after recieving the shingles vaccine and has a fever. Her daughter has been trying to give her gingerale and crackers but she keeps vomiting them up.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Herpes zoster, Hypoaesthesia, Rash
Clinical narrative: Severe lower back pain began and skin numbness from my back to abdomen. I thought it might be shingles but rash hadn't yet developed when I returned to doctor on 10/27 so he thought it was a pinched nerve. On 10/28 the rash started to develop and on 10/29 when I returned to the doctor he confirmed it was shingles.
Age: 0.95
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Irritability, Productive cough, Rhinorrhoea
Clinical narrative: Clear rhinorrhea, wet cough, decreased appetite, and fussiness for four days after vaccination.
Age: 0.26
Sex: M
Vaccine: HIBV, IPV
Symptoms: Hypophagia, Insomnia, Irritability
Clinical narrative: Decreased napping after the vaccinations.  Poor oral ingestion of fluids.  Fussiness since 6 a.m. on the day of the visit to see pediatrician on 10/31/2014.
Age: 0.36
Sex: F
Vaccine: DTAP, RVX
Symptoms: Crying, Insomnia, Restlessness, Vaccine positive rechallenge
Clinical narrative: HORRIBLY STIMULATED. As if given narcotics and strong stimulants. Cries for hours, cannot sleep. This is the same as what we experienced after her two-month vaccines. It is delayed and begins a few days afterwards. Child is in a state of complete unrest. Not normal irritability or restlessness -- extreme, animal-like.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood bicarbonate normal, Blood chloride normal, Blood creatinine increased, Blood glucose normal, Blood potassium normal
Clinical narrative: Acute fine sandpapery-vesicular-eruption on L biceps about 9 inches away from IM site where received flu shot. No fever. Non toxic. Labs unremarkable.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium normal, Blood urea normal, Eosinophil percentage increased, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Acute fine sandpapery-vesicular-eruption on L biceps about 9 inches away from IM site where received flu shot. No fever. Non toxic. Labs unremarkable.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Lymphocyte percentage increased, Neutrophil percentage decreased, Platelet count normal, Rash vesicular
Clinical narrative: Acute fine sandpapery-vesicular-eruption on L biceps about 9 inches away from IM site where received flu shot. No fever. Non toxic. Labs unremarkable.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count normal
Clinical narrative: Acute fine sandpapery-vesicular-eruption on L biceps about 9 inches away from IM site where received flu shot. No fever. Non toxic. Labs unremarkable.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Hallucination, auditory, Pain in extremity, Pyrexia
Clinical narrative: Four hours after shot both arms began to ache. Followed by chills and fever. Patient went to bed and heard voices during the night. Felt a bit strange the next day but all symptoms gone.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Develop chest tightness, mild SOB, lips and eyes are itchy. EPI PEN not administered - pt stated not severe. Sent to urgent care 1 mile away. BP 126/82, Pulse 65, Resp 16.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Gait disturbance, Mobility decreased, Pain in extremity
Clinical narrative: Patient states that left arm was sore after shot (later that evening) the soreness spread down his arm and to his hips and shins over the next week and a half. Patient continues to have pain with increasing discomfort. He complains of no other symptoms and has no redness or swelling at the injection. Pt is also taking CRESTOR. Pt struggles to lift arm and is having difficulty walking.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Tremor
Clinical narrative: Severe chills and shaking from 8:30-9:30 pm - no further treatment given.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Soreness in (L) shoulder, moved up to neck and into head, resulting in H/A lasting all day. 1st time pt. recd. flu shot in her life. No treatment sought. Pt is fine now but wanted to report this.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chest X-ray, Computerised tomogram, Eye pain
Clinical narrative: < 4 hours after - numbness in tongue. 48 hours after - paralyzed in whole right face, pain in eyes, mouth and head, loss of movement in closing eye and body weakness. Headaches. Treated at office and ER, CAT scan, MRI and placed on steroids for testing of GBS or Bell's Palsy.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid function disorder, Guillain-Barre syndrome, Headache, Hypoaesthesia oral, Nuclear magnetic resonance imaging
Clinical narrative: < 4 hours after - numbness in tongue. 48 hours after - paralyzed in whole right face, pain in eyes, mouth and head, loss of movement in closing eye and body weakness. Headaches. Treated at office and ER, CAT scan, MRI and placed on steroids for testing of GBS or Bell's Palsy.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Oral pain, VIIth nerve paralysis
Clinical narrative: < 4 hours after - numbness in tongue. 48 hours after - paralyzed in whole right face, pain in eyes, mouth and head, loss of movement in closing eye and body weakness. Headaches. Treated at office and ER, CAT scan, MRI and placed on steroids for testing of GBS or Bell's Palsy.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Lightheaded. Fatigued. Out of breath with very light activity. Headache.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Joint crepitation, Mobility decreased, Musculoskeletal pain, Pain, Skin warm
Clinical narrative: Severe pain on upper shoulder deltoid area, lost mobility and could not sleep on left arm. Could not raise arm above my head. I felt it was warm. It's now over 3 weeks and pain is extreme shoulder makes popping sounds and loud clicks.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: Severe pain on upper shoulder deltoid area, lost mobility and could not sleep on left arm. Could not raise arm above my head. I felt it was warm. It's now over 3 weeks and pain is extreme shoulder makes popping sounds and loud clicks.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Fever 99.9 F, Body aches, headache, fatigue, slight throat soreness, and mild cough.  Treatment: Stayed home sick for 2 days and slept it off.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever 99.9 F, Body aches, headache, fatigue, slight throat soreness, and mild cough.  Treatment: Stayed home sick for 2 days and slept it off.
Age: 27.0
Sex: M
Vaccine: FLUN4
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Pain, Pruritus, Rash, Tenderness
Clinical narrative: Itching on my upper left leg. Then the next day a few bumps appeared. By Wednesday my leg had several bumps and was painful to the touch.  Thursday I had more bumps breakout on my rear leg then my buttocks and my waistband on my back.  The rash continued to increase in size and was now painful at all times.   I was seen by the doctor on the 31st and told I had shingles.  This is on the same side I received my flu shot.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Weight bearing difficulty
Clinical narrative: Continual mild to moderate pain at site of injection in left shoulder. Difficulty lifting heavy objects. Taking daily naproxen.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Insomnia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in arm, shoulder, limited range of motion, difficulty sleeping due to shoulder pain in rotator cuff area.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Tendonitis
Clinical narrative: Pain in arm, shoulder, limited range of motion, difficulty sleeping due to shoulder pain in rotator cuff area.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Crying, Delirium, Depressed level of consciousness, Fatigue, Flushing
Clinical narrative: Acting fatigued, delirious (Mental Status changes/saying very bizarre things), dragging feet, pale, did not want to trick or treat very far, felt warm but looked pale, put to bed only 30 minutes later than normal with halloween & was asleep instantaneously. 1 hour later heard crying, not sure if missed this earlier. Found son to be crying/sobbing in bed and shaking but unarousable. Btwn me and his father, rubbing his back, and removing his pajamas and getting him to the ER, he was unarousable for a good estimated 40 minutes. When he did open his eyes he screamed about his mouth hurting and continued to cry. He appeared flushed, also said his head hurt (I assumed this from crying). We were able to get him under control at the ER with popsicles and DVD after some time. He was found to actually be afebrile. His strep test came back negative. He has never done anything like this before. He is always a very healthy child. He had not had any complaints prior. He does get the croup typically one time per year but other than that he does not even pick up the common cold so I thought he was a good candidate for the live attenuated virus. Not being able to arouse him while he cried and also his mental status changes/early evening drowsiness was a very scary experience.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Mental status changes, Oral pain, Pallor, Skin warm
Clinical narrative: Acting fatigued, delirious (Mental Status changes/saying very bizarre things), dragging feet, pale, did not want to trick or treat very far, felt warm but looked pale, put to bed only 30 minutes later than normal with halloween & was asleep instantaneously. 1 hour later heard crying, not sure if missed this earlier. Found son to be crying/sobbing in bed and shaking but unarousable. Btwn me and his father, rubbing his back, and removing his pajamas and getting him to the ER, he was unarousable for a good estimated 40 minutes. When he did open his eyes he screamed about his mouth hurting and continued to cry. He appeared flushed, also said his head hurt (I assumed this from crying). We were able to get him under control at the ER with popsicles and DVD after some time. He was found to actually be afebrile. His strep test came back negative. He has never done anything like this before. He is always a very healthy child. He had not had any complaints prior. He does get the croup typically one time per year but other than that he does not even pick up the common cold so I thought he was a good candidate for the live attenuated virus. Not being able to arouse him while he cried and also his mental status changes/early evening drowsiness was a very scary experience.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Streptococcus test positive, Tremor
Clinical narrative: Acting fatigued, delirious (Mental Status changes/saying very bizarre things), dragging feet, pale, did not want to trick or treat very far, felt warm but looked pale, put to bed only 30 minutes later than normal with halloween & was asleep instantaneously. 1 hour later heard crying, not sure if missed this earlier. Found son to be crying/sobbing in bed and shaking but unarousable. Btwn me and his father, rubbing his back, and removing his pajamas and getting him to the ER, he was unarousable for a good estimated 40 minutes. When he did open his eyes he screamed about his mouth hurting and continued to cry. He appeared flushed, also said his head hurt (I assumed this from crying). We were able to get him under control at the ER with popsicles and DVD after some time. He was found to actually be afebrile. His strep test came back negative. He has never done anything like this before. He is always a very healthy child. He had not had any complaints prior. He does get the croup typically one time per year but other than that he does not even pick up the common cold so I thought he was a good candidate for the live attenuated virus. Not being able to arouse him while he cried and also his mental status changes/early evening drowsiness was a very scary experience.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Tremor
Clinical narrative: DRY COUGH, CHEST CONGESTION. O2, RX HUMIDIFIER, ALBUTEROL INHALER. UNCONTROLABLE SHAKING. FEVER 102.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: Pain in back followed by vomiting and shortness of breath.  I used the inhaler I had from pneumonia and that helped breathing a little. By midnight I had chills, fever, more vomiting. At 1am on 11/1/2014 I had sever muscle pain.  11/1/2014 during the day I had a bad headache, nausea, chills and muscle aches.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pain in back followed by vomiting and shortness of breath.  I used the inhaler I had from pneumonia and that helped breathing a little. By midnight I had chills, fever, more vomiting. At 1am on 11/1/2014 I had sever muscle pain.  11/1/2014 during the day I had a bad headache, nausea, chills and muscle aches.
Age: 1.01
Sex: M
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site rash, Injection site swelling, Rash generalised
Clinical narrative: Started getting bumps all over right after the shot, then the sight of the shot doubled in size and has little bumps all over it, and hard as a rock. Now it is growing in size.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Diarrhoea, Eructation, Nausea, Urticaria
Clinical narrative: Chest pain, hives, vomiting, diarrhea, nauseous, egg burps.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Chest pain, hives, vomiting, diarrhea, nauseous, egg burps.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain
Clinical narrative: Generalized body aches and pain started Saturday night, worsened.  Patient self-treated with Flanax and Tylenol.  Pain continued for a week then left leg began to burn.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin discolouration, Skin warm
Clinical narrative: After flu shot, a large rectangular red area formed which was itchy and hot to touch and remained like this for 48 hours. After 48 hours, the area became black and blue.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity, Pruritus generalised, Urticaria
Clinical narrative: Arm got really sore and hurt to the light touch. I could not lift my arm up. Next day I got hives on my upper thighs, just a couple of spots and then it has been getting worse. The hives come and go. I'm still getting hives. Woke up last night at 3pm itching all over.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Eyelid oedema, Paraesthesia, Pruritus, Rash
Clinical narrative: Peri-oral rash, tingling in throat, puffiness in eyes, palms itching.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Fatigue, Influenza virus test negative, Lethargy, Pharyngitis, Pyrexia
Clinical narrative: It started with a fever and so I took him back to the doctor on 10/29/2014 at 8:20 AM they said he had a throat infection and sent him home with a prescription. His fever then got worse by that night at 6:00 PM I took him to the emergency room and they couldn't find any reason his fever was so high. his fever had gotten to 103.8 and he was lethargic. His fever lasted another 2 days. And now he is not very active and gets very tired easily and he is normally a very active baby.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Respiratory syncytial virus test negative, Streptococcus test negative
Clinical narrative: It started with a fever and so I took him back to the doctor on 10/29/2014 at 8:20 AM they said he had a throat infection and sent him home with a prescription. His fever then got worse by that night at 6:00 PM I took him to the emergency room and they couldn't find any reason his fever was so high. his fever had gotten to 103.8 and he was lethargic. His fever lasted another 2 days. And now he is not very active and gets very tired easily and he is normally a very active baby.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Patient's left arm became very swollen, painful, red, and hot following her Pneumovax vaccination. She stated that it continued to spread and was all the way down to her elbox at time of reporting.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm started swelling getting red, painful to touch and is itchy all started on 11-1-14 in the morning as the day progress the redddness started spreading up to neck and down arm. Patient instructed to start taking benadrly for itching to arm and ibuprofen for pain to left arm and can apply a cold compress to site to help easy swelling.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Herpes zoster, Laboratory test normal
Clinical narrative: Daughter received HPV on 9/30/2013 and 12/5/2013 recently daughter was diagnosed with shingles which led into issues with walking.  All tests are coming back negative and not sure why she is having issues walking.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Blister rupture, Injection site vesicles
Clinical narrative: Blister at site of injection, that ruptured while in bed.  She came in to report it on 11/2/14 at 2pm.  It appears to be healing, but slowly according to the patient.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Soreness in shoulder joint that has resulted in limited mobility of shoulder joint and arm much like a frozen shoulder due to the injection being placed high on the arm near shoulder joint.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Paitent had redness and hardness at site of injection. We told to ice for 15 minutes and use analgesic if could tolerate.
Age: 52.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Member stated he felt alittle itchy and developed hives systemically. Patient states that he never developed any shortness or difficulty breathing.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: Red rash swollen aprox 5 inches in diameter hot and itchy.  tx Benadryl, ibuprofen, cool compress.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Myalgia, Nausea, Vertigo
Clinical narrative: Severe vertigo; nausea; within 4 hrs. had oral temp of 100.9, fatigue, aching in muscles, mostly in upper back. Symptoms continued for 1 1/2 days then disappeared after extra rest. No other symptoms.  No rash.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site rash, Pain in extremity
Clinical narrative: Patient reports severe chills, soreness in arm and severe rash at site of injection.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site rash, Pain in extremity
Clinical narrative: Patient reports chills, soreness in arm and severe rash at site of injection.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Itching and Hives on right arm, shoulder, and back - recommended that she seek medical attention and monitoring from a doctor due to her allergic reaction and concern that it could continue into a more severe allergic reaction.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Vaccine was given in the right thigh.  On the 5th day, the right thigh became swollen to twice the size of the left and normal thigh.  It had a hive like rash that was red and felt hot to the touch.  It was itchy.  There was no fever or pain.  It did NOT respond to Benadryl.  It remained the same for 3 days, but went from red to pink.  It fully disappeared the 4th day.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Vaccine was given in the right thigh.  On the 5th day, the right thigh became swollen to twice the size of the left and normal thigh.  It had a hive like rash that was red and felt hot to the touch.  It was itchy.  There was no fever or pain.  It did NOT respond to Benadryl.  It remained the same for 3 days, but went from red to pink.  It fully disappeared the 4th day.
Age: 49.0
Sex: M
Vaccine: FLUN4
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: No adverse event noted. Found out post administration that pt is actively taking weekly Copaxone 200mg injection for M.S. and shouldn't be taking any live virus vaccination. Pt followed up via phone call and states doing well and will f/u with his neurologist this coming week.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Chest pain, Herpes zoster, Pain, Rash
Clinical narrative: Typical post flu shot symptoms, but started severe dull pain in back and chest, never ceasing, develop a rash on chest, few days later diagnost: shingles. Never have had chicken pox. 5 weeks later still sufering from pain. Rash has cleared up.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Wheezing
Clinical narrative: Wheezing, headache, fatigue.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Nausea, Oropharyngeal pain
Clinical narrative: In this order: severe sore throat, slight nausea, chills, diarrhea, head-ache when walking. All came within a half hour, the chills being the most severe.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Swelling of upper lip, lasting over 12 hours, subsided with Benadryl. Lip swelling recurred 10/23/2014 and 10/27/2014 along with hives and itching. Treated with Benadryl.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Apparent reaction to flu shot Got shot on 10/28/14. 10/29/14 redness at injection site and swollen was prescribed prednisone by nurse practitioner on 10/30 and is fine. Followed up with patient on 11/2 swelling and redness gone.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Acne, Injection site dryness, Injection site erythema, Pruritus
Clinical narrative: "Pimples" that are itchy appeared on patient's lower back approx. 1 week after flu shot. Also has redness/dryness around injection site. He is seeing his doctor later this week to be evaluated.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was at Dr. office for something else and had PA look at arm where PNEUMOVAX 23 was administered. It was red, hot, and swollen. Approx 6 inch by 5 inch on deltoid.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt complained arm very sore, hot red circle on left arm.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of swelling and redness at injection site. Patient took 25mg of BENADRYL OTC and reported some decrease. Instructed to continue BENADRYL and take MOTRIN, return if fever or increased swelling.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Pt complains of numbness extending from shoulder to elbow. Pt says progressively worse.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Patient received seasonal flu and pneumonia immunization in left arm by request - arm became swollen, red, inflamed and warm - saw MD and was diagnosed w/ cellulitis - received a course of levofloxacin and recovered w/ no additional therapy.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site infection, Injection site inflammation, Syringe issue
Clinical narrative: Husband was in to pick up a Rx for her. Said she had localized site inflammation and infection at injection site. Hospital physician said was due to needle not retracting properly into lumen of the self-retracting syringe.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: 2 days after ADACEL shot pt had red arm several inches big that wrapped 3/4 of way of arm.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Parosmia
Clinical narrative: Pt says that shortly after his shot, he started smelling gasoline - like odor. He stopped by the pharmacy 11/2/14 and says that he still feels like he is smelling gasoline.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Eye swelling, Inflammation, Ocular hyperaemia, Pruritus
Clinical narrative: Inflammation, redness in neck and right side of face particularly nose, right eye. Slight itching and bumps. A lot of swelling at rt. eye. Went to PCP 10/29, put on course of prednisone. Sx clearing as of today (11/3/14). Rash started on rt arm when I went to see PCP, now clear.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Inflammation, redness in neck and right side of face particularly nose, right eye. Slight itching and bumps. A lot of swelling at rt. eye. Went to PCP 10/29, put on course of prednisone. Sx clearing as of today (11/3/14). Rash started on rt arm when I went to see PCP, now clear.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture, Blood test, Injection site erythema, Injection site urticaria, Pyrexia
Clinical narrative: On 10/30/14 patient received two vaccinations: one was for the flu (Rx # 0504505 FLUZONE QUAD); and the other was for pneumonia (Rx # 0504506 PNEUMOVAX 23 vial). Early on 10/31/14 a red welt-like patch appeared at the site of the pneumonia injection. It got much worse, accompanied by fever. Went to the ER at Hospital and was admitted.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: X-ray
Clinical narrative: On 10/30/14 patient received two vaccinations: one was for the flu (Rx # 0504505 FLUZONE QUAD); and the other was for pneumonia (Rx # 0504506 PNEUMOVAX 23 vial). Early on 10/31/14 a red welt-like patch appeared at the site of the pneumonia injection. It got much worse, accompanied by fever. Went to the ER at Hospital and was admitted.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Throat irritation, Urticaria
Clinical narrative: Pt received TDAP and 30 minutes later c/o scratchy throat and hives face red. Pt stated she has allergies but not to TDAP. RN and another employee spoke with supervisor and had another member of pt's team drive pt to urgent care for follow up. Pt has her own Epipen and brought with her in car to urgent care. Pt returned to facility at 3:30 but immediately drove home unable to get report from pt on what services she received from urgent care.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency, route not reported). No concomitant medications were reported. On an unknown date the patient developed a "little" redness and swelling at the injection site as well as "what looks like" a shingles rash at an unspecified location after receiving ZOSTAVAX. The outcome of the events is unknown. The causality of the events was not specified. Additional information is not expected as the pharmacist declined to provide any further information and there were no contact details available.
Sex: F
Vaccine: PPV
Symptoms: Insomnia
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. In 2002 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot#, dose and route unspecified) and no adverse effects reported with the first dose. On 24-OCT-2014 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot#, dose and route unspecified). The reporter stated that she had difficulty sleeping that night (on 24-OCT-2014). The outcome of the event was unknown. Additional information is not expected as lack of contact details for the partner.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # H019038 and expiry date 17-JAN-2014, dose 1, 0.65 milliliters, subcutaneous. On 29-OCT-2014, the patient received expired dose. The patient experienced no adverse effect. A product quality complaint has been filed. The outcome of received expired dose and no adverse effect is unknown. The reporter considered received expired dose and no adverse effect to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 30-OCT-2014, the patient was vaccinated with improperly stored PNEUMOVAX 23, (single dose vial), 0.5 ml, intramuscularly, exposed to 66 Fahrenheit (F) for 15 hours. No concomitants were reported. No adverse effect was reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient beganto have severe nausea and vomiting and headache about 3 hrs following vaccine. Same symptoms again today (11-2-14).