chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Throat tightness, Vision blurred
Clinical narrative: Employee received 2010-2011 flu vaccine (FLUZONE) and felt like throat was closing up. Pt had headaches and blurred vision as well as dizziness briefly. Pt went to ER was placed on steroid, BENADRYL, and PEPCID. Of note employee has had influenza in the past without problems. She opted not to receive H1N1 last year. It is highly possible that pt had an issue with the H1N1 component from this year flu batch.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Antibody test, Blood glucose, CSF protein increased, Cardiac function test, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Initial unsolicited report received from consumer on 20 April 2015. A male patient, whose medical history was reported as penicillin allergy and age, concomitant medication were not reported, had received a dose of FLUZONE batch number UH907AL, (expiration date, dose, dose cycle and route of administration not reported) in left deltoid on 18 October 2013. On an unspecified date, four weeks after vaccination patient had experienced symptoms of tingling in legs when stretching, numbness in the bottoms of feet and moving up legs progressively. Patient also experienced tingling in hand up arms and body, on April 2014. Patient was further diagnosed with Distal acquired demyelinating symmetric (DADS) version chronic inflammatory demyelinating polyneuropathy. It was reported that, in April 2014 patient did blood work up and Multiple Sclerosis Spinal Tap showed protein. The patient's laboratory investigation includes, cardiac workup and blood glucose levels, Electromyography (EMG) and Anti Mag test results were unknown, thyroid Magnetic resonance imaging (MRI) 3 levels was negative, Spinal tap result was Lymes ruled out. The patient had required ER/doctor visit. Illness at time of vaccination was reported as none. Upon internal review, company assessed the event of chronic Inflammatory Demyelinating Polyradiculoneuropathy, experienced tingling in legs when stretching/tingling in hand up arms and body and numbness in the bottoms of feet and moving up my legs progressively as serious and important medical event. At the time of this report, patient was not recovered from events. List of the document held by sender: None.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Initial unsolicited report received from consumer on 20 April 2015. A male patient, whose medical history was reported as penicillin allergy and age, concomitant medication were not reported, had received a dose of FLUZONE batch number UH907AL, (expiration date, dose, dose cycle and route of administration not reported) in left deltoid on 18 October 2013. On an unspecified date, four weeks after vaccination patient had experienced symptoms of tingling in legs when stretching, numbness in the bottoms of feet and moving up legs progressively. Patient also experienced tingling in hand up arms and body, on April 2014. Patient was further diagnosed with Distal acquired demyelinating symmetric (DADS) version chronic inflammatory demyelinating polyneuropathy. It was reported that, in April 2014 patient did blood work up and Multiple Sclerosis Spinal Tap showed protein. The patient's laboratory investigation includes, cardiac workup and blood glucose levels, Electromyography (EMG) and Anti Mag test results were unknown, thyroid Magnetic resonance imaging (MRI) 3 levels was negative, Spinal tap result was Lymes ruled out. The patient had required ER/doctor visit. Illness at time of vaccination was reported as none. Upon internal review, company assessed the event of chronic Inflammatory Demyelinating Polyradiculoneuropathy, experienced tingling in legs when stretching/tingling in hand up arms and body and numbness in the bottoms of feet and moving up my legs progressively as serious and important medical event. At the time of this report, patient was not recovered from events. List of the document held by sender: None.
Age: 0.26
Sex: M
Vaccine: HIBV, RV5
Symptoms: Infantile spitting up, Irritability
Clinical narrative: Fussy for 30 minutes, took three hours to calm him. More spitting up.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of L Deltoid/upper arm, warm to touch, tender, and itchy 2 hours post vaccination. Patient came in 2 days later with reduced swelling, treated itching with Zyrtec. Patient assessed by PCM and Immunizations clinic Nurse.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Muscle pain, pain at injection site, arm soreness, headache, sore throat, no appetite, fatigue.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Muscle pain, pain at injection site, arm soreness, headache, sore throat, no appetite, fatigue.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever as high as 103. Headache. Diarrhea. Soreness at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, and hot to touch on (L) deltoid area-extending toward elbow 85 x 85 mm.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dehydration, Vomiting
Clinical narrative: Vomiting occurring within 4 hours of administration. Home care until he showed signs of dehydration 24 hours after.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Fatigue, Injection site rash
Clinical narrative: Dizziness, loss of appetite, fatigue, rash at injection site, ringing in ears, fever, stomach ache.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Dizziness, loss of appetite, fatigue, rash at injection site, ringing in ears, fever, stomach ache.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Headache, Injection site pain
Clinical narrative: Severe headache and flushing for two days. Severe arm pain on site of injection for a few hours.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Dizziness, Myalgia
Clinical narrative: On 4/29 noticed at 8 am that began to feel muscle pain on back (let and right side) as morning progressed muscle soreness on rib cage started. In afternoon, developed lightheadedness and stomach problems. Symptoms similar to flu. Has not called doctor yet.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Vasovagal syncope during fingerstick procedure approximately 3 minutes after HPV #1 IM injection. Pt noted to be shaking and not responsive, immediately laid down and immediately began to respond. No loss of urine, no previous hx of seizures or fainting. BP 110/70, pulse 71, Sat 100%. No post ictal period. Feeling fully recovered in a few minutes. Stayed lying down x 20" 98/68, 62, 98%. Sat up x 20" 100/70, 71 and 99%. Felt well and stable when left office.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Hypotonia, Presyncope
Clinical narrative: Vasovagal syncope during fingerstick procedure approximately 3 minutes after HPV #1 IM injection. Pt noted to be shaking and not responsive, immediately laid down and immediately began to respond. No loss of urine, no previous hx of seizures or fainting. BP 110/70, pulse 71, Sat 100%. No post ictal period. Feeling fully recovered in a few minutes. Stayed lying down x 20" 98/68, 62, 98%. Sat up x 20" 100/70, 71 and 99%. Felt well and stable when left office.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary mass, Lymphadenopathy, Skin warm, Tenderness
Clinical narrative: Patient noticed moderate (R) axillary swelling/lymphadenopathy with a tendor, palpable lump. Skin is warm to touch; patient is afebrile.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: Site of MMRV presented to Dr 4/30/15. Dr. considers it side effect, no adverse event. Fever, rash, swelling.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Allergy test negative, Anaphylactic reaction, Blood test, Eye swelling, Rash
Clinical narrative: Hives started breaking out at approx. 7pm of 03/03/15.  03/04/15 - 8am face/eyes swelling. Symptoms continue daily. 03/24/2015 - 4pm anaphylaxis - ER visit. 03/26/2015 - 1pm anaphylaxis - on air plane. 04/28/2015 - 9pm anaphylaxis - ER visit. Have seen primary care Dr, allergist, immunologist.  25 days of prednisone starting 3/24 to 4/15 (hives/swelling/rash continued throughout treatment). Medications - Prednisone, Singulair, Atarax, Zantac, Benadryl, Epi-Pen. Hives/Swelling/Rash are currently present daily.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives started breaking out at approx. 7pm of 03/03/15.  03/04/15 - 8am face/eyes swelling. Symptoms continue daily. 03/24/2015 - 4pm anaphylaxis - ER visit. 03/26/2015 - 1pm anaphylaxis - on air plane. 04/28/2015 - 9pm anaphylaxis - ER visit. Have seen primary care Dr, allergist, immunologist.  25 days of prednisone starting 3/24 to 4/15 (hives/swelling/rash continued throughout treatment). Medications - Prednisone, Singulair, Atarax, Zantac, Benadryl, Epi-Pen. Hives/Swelling/Rash are currently present daily.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Antibody test, Biopsy skin, Blood test, Eye swelling, Lip swelling
Clinical narrative: Hives started breaking out at approx. 7pm of 03/03/15.  03/04/15 - 8am face/eyes swelling. Symptoms continue daily. 03/24/2015 - 4pm anaphylaxis - ER visit. 03/26/2015 - 1pm anaphylaxis - on air plane. 04/28/2015 - 9pm anaphylaxis - ER visit. Have seen primary care Dr, allergist, immunologist.  25 days of prednisone starting 3/24 to 4/15 (hives/swelling/rash continued throughout treatment). Medications - Prednisone, Singulair, Atarax, Zantac, Benadryl, Epi-Pen. Hives/Swelling/Rash are currently present daily.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Swelling face, Throat tightness, Urticaria
Clinical narrative: Hives started breaking out at approx. 7pm of 03/03/15.  03/04/15 - 8am face/eyes swelling. Symptoms continue daily. 03/24/2015 - 4pm anaphylaxis - ER visit. 03/26/2015 - 1pm anaphylaxis - on air plane. 04/28/2015 - 9pm anaphylaxis - ER visit. Have seen primary care Dr, allergist, immunologist.  25 days of prednisone starting 3/24 to 4/15 (hives/swelling/rash continued throughout treatment). Medications - Prednisone, Singulair, Atarax, Zantac, Benadryl, Epi-Pen. Hives/Swelling/Rash are currently present daily.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Respiratory arrest
Clinical narrative: Mother contacted office that child was turning blue and not breathing.  Advised to call 911 and child admitted to hospital with O2 sats in the 70's and remains there with multiple physician consults.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Localized reaction.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling the size of a lemon or smaller.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles in T1 dermatomal distribution involving the right upper extremity (same as vaccine administration site), axilla, chest, and back.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abasia, Asthenia, Endotracheal intubation, Hypersensitivity, Hypoventilation
Clinical narrative: Patient is our 15 month old that presents with weakness and altered mental status after receiving her 15 month vaccine today. She was in her usual state of health and went to her PCP for her 15 month checkup. She received her vaccine (dtap? mom unsure what was obtained). The left leg where the vaccine was administered was shaking shortly after the shot. Within minutes of leaving the office she had a "goofy look" on her face and could not walk. Immediately went to the ER where she continued to wax and wane. She had a GCS of 7 and the decision was made to intubate her. Life flight was called and on arrival noted that she was being hypoventilated with TV in the 50s which they increased to 100. Initial gas was 7.14/73/25/-5. Subsequently admitted to PICU. Mom notes that something similar has happened twice in the past. First was after her 12 month vaccines where she was also weak and altered that resolved within 24 hours. Second episode was not associated with vaccines but had a URI. She woke up weak and altered and this also self resolved within 24 hours. No seizure activity in the past. Seizure history on both sides of family. Hx of head trauma and skull fracture when she was ~ 8 months old when she was crawling and fell back on her head. Denies any intervention. ROS negative aside from runny nose which has been attributed to allergies. Denies fevers, sick contacts, diarrhea, rashes.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site reaction, Intensive care, Mental status changes, Rhinorrhoea, Tremor
Clinical narrative: Patient is our 15 month old that presents with weakness and altered mental status after receiving her 15 month vaccine today. She was in her usual state of health and went to her PCP for her 15 month checkup. She received her vaccine (dtap? mom unsure what was obtained). The left leg where the vaccine was administered was shaking shortly after the shot. Within minutes of leaving the office she had a "goofy look" on her face and could not walk. Immediately went to the ER where she continued to wax and wane. She had a GCS of 7 and the decision was made to intubate her. Life flight was called and on arrival noted that she was being hypoventilated with TV in the 50s which they increased to 100. Initial gas was 7.14/73/25/-5. Subsequently admitted to PICU. Mom notes that something similar has happened twice in the past. First was after her 12 month vaccines where she was also weak and altered that resolved within 24 hours. Second episode was not associated with vaccines but had a URI. She woke up weak and altered and this also self resolved within 24 hours. No seizure activity in the past. Seizure history on both sides of family. Hx of head trauma and skull fracture when she was ~ 8 months old when she was crawling and fell back on her head. Denies any intervention. ROS negative aside from runny nose which has been attributed to allergies. Denies fevers, sick contacts, diarrhea, rashes.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness on site of injection per patient.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on legs and face, low grade fever.
Age: 55.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Feeling abnormal, Hypoaesthesia, Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: PT POSTED ON FACEBOOK THAT SHE FELT LIKE CRUD. CALLED TO CHECK ON HER YESTERDAY AFTER HEARING THAT. SHE SAID ARM WAS SORE. TODAY SHE CALLED AND STATED THAT HER ARM WAS NUMB, AND COULDN'T LIFT ANYTHING WITH IT AND THAT SHE COULD NOT RAISE HER ARM ABOVE HER SHOULDER WITH OUT PAIN.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Neck tender to the touch. Glands swollen and around the Adams apple.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Tenderness and swelling at injection site. Then a blister and serious bruising three (3) inches below injection site three days after injection. Cleaned area with alcohol and bicitracin.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Red, raised rash and swelling on right thigh on and around injection site.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red, raised rash that resembled mosquito bites on and around four injection sites which include right and left upper arm and right and left thighs.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, MMR, PPV, VARCEL
Symptoms: Injection site movement impairment, Injection site pain, Pyrexia, Swelling face
Clinical narrative: Fever of 101.7, puffy face especially around eyes, pain at the site of injection, doesn't want to stand or move legs (shots in both thighs). It's currently 1847 on 5/1/2015 and symptoms remain.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Blood test normal, Influenza virus test negative, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Fever of 101.7. White blood cell count was doubled.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Generalized erythematous rash
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Fever, localized erythema and swelling.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Cellulitis
Clinical narrative: Cellultis. Tx: CEPHALEXIN 250 mg/5 ml, 5 ml tid x 10 days
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Skin infection
Clinical narrative: Vaccine was given to pt. Next day pt developed skin infection due to vaccine. (L) thigh. Med was Rx to pt KEFLEX BID x 7 days, F/U in 2 wks.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Premature labour, Premature rupture of membranes
Clinical narrative: My water broke and I went into preterm labor at only 35 weeks pregnant. I had a perfectly healthy pregnancy with no signs of anything wrong until I got the Tdap vaccine and 8 hrs later if went into labor.  Additionally, I developed a bad egg allergy/intolerance from the date of the shot.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Lump and welt appeared at injection site. I traced a circle around the lump to see if it grew throughout the day, which it did. It's now hot to the touch, itchy, painful, and significantly larger.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102.5 followed by a rash on stomach. Next day fever again and by night time the rash was also on his face.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Breath odour, Erythema, Fluid intake reduced, Gingival bleeding, Gingival erythema
Clinical narrative: Started with a fever around 101 degrees. Noticed a red spot on patient's cheek. The next day (04/28/2015) she had a spot on her lip, leg, and hand. Still on and off with a fever around 100-101 degrees. On 04/29/2015 her gums bled after brushing her teeth (this has never happened before). Her gums seemed a little bit red, still on and off with a 100-101 degree fever. On 04/30/15 her gums bled a little bit while brushing her teeth again, and on and off with the same 100-101 degree fever. On 05/01/2015, she still a 100 degree fever. Her gums bled again and looked very red and irritated. There was a spot on her tongue and a couple spots in her mouth and she had bad breath. Called the doctor & they said to bring her in. He informed us that she had Gingivo-Stomatitis. (Claimed it was not from the vaccine, but I researched and found out the virus is caused by: varicella, herpes simplex 1 virus, coxsackie virus, and measles, so it was most likely from the vaccine!) He said she is at the tail end of the virus and to keep giving her Tylenol if she is uncomfortable. She hasn't been eating or drinking as much, especially on 5/1.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Gingival pain, Hypophagia, Oral mucosal eruption, Pyrexia, Stomatitis
Clinical narrative: Started with a fever around 101 degrees. Noticed a red spot on patient's cheek. The next day (04/28/2015) she had a spot on her lip, leg, and hand. Still on and off with a fever around 100-101 degrees. On 04/29/2015 her gums bled after brushing her teeth (this has never happened before). Her gums seemed a little bit red, still on and off with a 100-101 degree fever. On 04/30/15 her gums bled a little bit while brushing her teeth again, and on and off with the same 100-101 degree fever. On 05/01/2015, she still a 100 degree fever. Her gums bled again and looked very red and irritated. There was a spot on her tongue and a couple spots in her mouth and she had bad breath. Called the doctor & they said to bring her in. He informed us that she had Gingivo-Stomatitis. (Claimed it was not from the vaccine, but I researched and found out the virus is caused by: varicella, herpes simplex 1 virus, coxsackie virus, and measles, so it was most likely from the vaccine!) He said she is at the tail end of the virus and to keep giving her Tylenol if she is uncomfortable. She hasn't been eating or drinking as much, especially on 5/1.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Tongue eruption
Clinical narrative: Started with a fever around 101 degrees. Noticed a red spot on patient's cheek. The next day (04/28/2015) she had a spot on her lip, leg, and hand. Still on and off with a fever around 100-101 degrees. On 04/29/2015 her gums bled after brushing her teeth (this has never happened before). Her gums seemed a little bit red, still on and off with a 100-101 degree fever. On 04/30/15 her gums bled a little bit while brushing her teeth again, and on and off with the same 100-101 degree fever. On 05/01/2015, she still a 100 degree fever. Her gums bled again and looked very red and irritated. There was a spot on her tongue and a couple spots in her mouth and she had bad breath. Called the doctor & they said to bring her in. He informed us that she had Gingivo-Stomatitis. (Claimed it was not from the vaccine, but I researched and found out the virus is caused by: varicella, herpes simplex 1 virus, coxsackie virus, and measles, so it was most likely from the vaccine!) He said she is at the tail end of the virus and to keep giving her Tylenol if she is uncomfortable. She hasn't been eating or drinking as much, especially on 5/1.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 105.4.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Diabetes mellitus, Vomiting
Clinical narrative: Vomiting every half hour 12/12/14 and 12/13/14, Diarrhea 12/14/14 and 12/15/14.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Achy, weak legs.  Kept me up 2-3 hrs. during the first night.  Symptoms have continued daily since my shot and am having trouble doing every day things.  My arms were very weak the first 2-3 weeks, some still remains.  Main concern is my legs.  Walking, sitting, standing all cause weakness. I am going to contact my physician again on Monday to see what recourse they can take to somehow correct the physical problems I am having.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Condition aggravated, Dizziness, Hernia pain, Hyperhidrosis
Clinical narrative: Swelling and pain of throat and hernia/chest. Slight fever and sweating/dizziness. It was the hernia that took the brunt of the reaction and was very painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Swelling and pain of throat and hernia/chest. Slight fever and sweating/dizziness. It was the hernia that took the brunt of the reaction and was very painful.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: Patient came into the pharmacy in the early evening (about 5:00 PM) on 05/01/2015 to inquire about what appeared to be a site reaction likely due to the Zostavax she received on 4/29/15 from pharmacist.  She was pleasant and seemed only mildly concerned. I examined the area and informed her that it did look like she had a localized site reaction due to the vaccine and that it did sometimes occur in some patients.  It was about 2 to 3 inches in diameter and was red.  Patient also said she could feel a hard lump underneath the area when touching it with her fingers.  She said it was not painful. She did not complain of any other symptoms.  I told her that it would probably go away on it's own within a few days but that if it got worse, did not improve or if other symptoms developed to call her primary doctor.  She agreed and left the store.  I followed up with her this morning by calling her at home and she said that the area had not yet improved.  I advised her that she could apply some ice to the area to try to reduce some of the redness.  I faxed notification of the adverse event to both the protocol physician as well as to the patient's primary physician at about 4:15 PM on 05/02/15 as I could not reach them on the phone over the weekend. I also documented the adverse event through the corporate reporting system as well as notifying both our pharmacy supervisor and the immunization coordinator.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Patient had swelling at the injection 2 days post injection. Patient went to local walk-in clinic and was determined to have cellulitis at the injection site.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Arthritis, Eye swelling, Lethargy, Mouth swelling, Pharyngeal oedema
Clinical narrative: Severe hives, arthritis, lethargy, swollen eyes, swollen mouth and throat.  Airway monitored and was never obstructed.  Symptoms lasted 7 days.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Severe hives, arthritis, lethargy, swollen eyes, swollen mouth and throat.  Airway monitored and was never obstructed.  Symptoms lasted 7 days.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS- now a chronic illness.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Got vaccinated 4/22/15. Friday 4/24 developed lump, redness warmth in area of shot. No fever no other symptoms. 4/28/15-still red and warm to touch.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Local swelling, Skin warm
Clinical narrative: 8 yr M received Hep-B #4, needed because spacing for Hep B series was given < 3 mths. Given 9-9-14 by PHN. IM/LA. S and S. Local swelling x 2 days, warm to touch. Client rtn to school. No PCP. No fever.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Asthenia, Autism, Crying, Fatigue, Pyrexia
Clinical narrative: My son was laying in my arms the evening of his vaccinations. He had 4 vaccinations administered. He cried much of the day and had a fever up to 102. While in my arms he had a seizure. We did not seem treatment. I spoke to a family member who is a nurse and I kept a close eye on my son. He was tired and a little weak afterward. The next day he didn't seem to have any remaining effects of the seizure. He is now nonverbal and has since been diagnosed with Autism.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Seizure, Speech disorder
Clinical narrative: My son was laying in my arms the evening of his vaccinations. He had 4 vaccinations administered. He cried much of the day and had a fever up to 102. While in my arms he had a seizure. We did not seem treatment. I spoke to a family member who is a nurse and I kept a close eye on my son. He was tired and a little weak afterward. The next day he didn't seem to have any remaining effects of the seizure. He is now nonverbal and has since been diagnosed with Autism.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Rash erythematous, Rash maculo-papular
Clinical narrative: Round, raised, erythematous, maculopapular, confluent red rash approx. 5 inches in circumference circumventing injection site on right lateral thigh. Rash lasted 3 days without any specific treatements. Was painful or pruritic per toddler.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, Periarthritis, Restlessness
Clinical narrative: Persistent pain no relief frozen sholder limited movememt had cortisone shot to no relief had pt treatment to no relief still in constant pain very much restless nights.
Age: 53.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Middle insomnia
Clinical narrative: Site of inject swelled and got hard/red and burned. For the next week went to sleep easily but woke up nightly between 2:00 and 3:30 AM wide and wake and couldn't get back to sleep.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Facial pain, Pain in jaw, Pruritus, Viral parotitis, X-ray dental
Clinical narrative: Itching four 12 hours starting about 20 minutes after administered (stopped after 50mg po Benadryl). On 3/20 developed pain in R jaw/cheek area, started OTC ibuprofen. Seen at employee health on 3/30/15 and given tramadol for the pain; returned to employee heath on 4/6/15 and had panorex x-rays done; diagnosed with viral parotitis secondary to MMR vaccine. Continue to follow up with employee health since symptoms continue.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Dysgeusia, Nausea
Clinical narrative: We called 911 pt had dizziness, nausea, diarrhea, metallic taste in mouth. 911 released pt to go home on their own.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Patient reported numbness in left arm and left side of head. Described as if he had been laying on arm and went to sleep. Said he was sweating and felt woozy. Started 20 min after administration and lasted 20 min. He remained seated, gave air from fan, took Be and gave water.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site vesicles, Pain in extremity, Peripheral swelling
Clinical narrative: -Swelling, redness, pain on whole upper left arm -Blister on injection site -Advised pt to seek med help today (now).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced dizziness, vomiting, difficulty breathing, sore arm, red arm, swollen arm, itchy arm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Vomiting
Clinical narrative: Patient experienced dizziness, vomiting, difficulty breathing, sore arm, red arm, swollen arm, itchy arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Chest X-ray normal, Computerised tomogram thorax, Echocardiogram, Respiratory tract infection
Clinical narrative: Exacerbation of asthma - vaccine date 3/20/15 - respiratory infection started 3/21/15 - asthma exacerbation started 3/30/15
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Spirometry
Clinical narrative: Exacerbation of asthma - vaccine date 3/20/15 - respiratory infection started 3/21/15 - asthma exacerbation started 3/30/15
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt received Pneumonia vaccine to left deltoid on 8/13/14, and the next evening he developed firmness at the site of the injection, redness, warmth, soreness, aching all over (flu-like symptoms), chills, nausea. The site was so tense, pt states it had ridges on skin. S/S were worse at 6-7 pm yesterday. Pt took TYLENOL, with some relief of aching. Myalgia, Rash and Nausea Vomiting. Treatment: Acetaminophen.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Myalgia, Nausea, Pain, Rash
Clinical narrative: Pt received Pneumonia vaccine to left deltoid on 8/13/14, and the next evening he developed firmness at the site of the injection, redness, warmth, soreness, aching all over (flu-like symptoms), chills, nausea. The site was so tense, pt states it had ridges on skin. S/S were worse at 6-7 pm yesterday. Pt took TYLENOL, with some relief of aching. Myalgia, Rash and Nausea Vomiting. Treatment: Acetaminophen.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Pt received Pneumonia vaccine to left deltoid on 8/13/14, and the next evening he developed firmness at the site of the injection, redness, warmth, soreness, aching all over (flu-like symptoms), chills, nausea. The site was so tense, pt states it had ridges on skin. S/S were worse at 6-7 pm yesterday. Pt took TYLENOL, with some relief of aching. Myalgia, Rash and Nausea Vomiting. Treatment: Acetaminophen.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Swelling
Clinical narrative: Swelling.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain
Clinical narrative: Red, swelling, pain beginning at injection site. Pain and numb down right arm to fingertips. Tingling in right arm and hand. Ringing in ears. Headaches in back of head-daily. Visit my doctor 3x - Neurologist 1x. No relief. No cure. Dropping items. Can't work right arm.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Grip strength decreased, Headache, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Red, swelling, pain beginning at injection site. Pain and numb down right arm to fingertips. Tingling in right arm and hand. Ringing in ears. Headaches in back of head-daily. Visit my doctor 3x - Neurologist 1x. No relief. No cure. Dropping items. Can't work right arm.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Musculoskeletal disorder, Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: Red, swelling, pain beginning at injection site. Pain and numb down right arm to fingertips. Tingling in right arm and hand. Ringing in ears. Headaches in back of head-daily. Visit my doctor 3x - Neurologist 1x. No relief. No cure. Dropping items. Can't work right arm.
Age: 48.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in a 48-year-old male patient who received ENGERIX B pediatric (batch number 4257X, expiry date 9th April 2016). Previously administered products included ENGERIX B adult with an associated reaction of no reaction on previous exposure to drug (dose 1) and ENGERIX B adult with an associated reaction of no reaction on previous exposure to drug (dose 2). On 21st April 2015, the patient received ENGERIX B pediatric (intramuscular) .5 ml. On an unknown date, immediately after receiving ENGERIX B pediatric, the patient experienced burning sensation, rash and underdose. On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the rash was recovering/resolving and the outcome of the underdose was unknown. The reporter considered the burning sensation and rash to be almost certainly related to ENGERIX B pediatric. Additional information received: Patient received ENGERIX B pediatric instead of ENGERIX B adult as the 3rd dose in series, that led to underdose. Patient stated that it burned at the time of administration, and a few hours later, a rash developed on his right arm. Within a couple of days the rash had spread to his left arm and left leg. No other immunizations were given at the time.
Age: 48.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Burning sensation, Drug administered to patient of inappropriate age, Immediate post-injection reaction, Rash, Underdose
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in a 48-year-old male patient who received ENGERIX B pediatric (batch number 4257X, expiry date 9th April 2016). Previously administered products included ENGERIX B adult with an associated reaction of no reaction on previous exposure to drug (dose 1) and ENGERIX B adult with an associated reaction of no reaction on previous exposure to drug (dose 2). On 21st April 2015, the patient received ENGERIX B pediatric (intramuscular) .5 ml. On an unknown date, immediately after receiving ENGERIX B pediatric, the patient experienced burning sensation, rash and underdose. On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the rash was recovering/resolving and the outcome of the underdose was unknown. The reporter considered the burning sensation and rash to be almost certainly related to ENGERIX B pediatric. Additional information received: Patient received ENGERIX B pediatric instead of ENGERIX B adult as the 3rd dose in series, that led to underdose. Patient stated that it burned at the time of administration, and a few hours later, a rash developed on his right arm. Within a couple of days the rash had spread to his left arm and left leg. No other immunizations were given at the time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Infection, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Very red where shot was administrated. Red rash began spreading down arm and arm hurt. The next day Saturday, 2/21 the rash began spreading even more and arm began swelling. On Sunday, 2/22 there was less pain but the rash was still very red and spreading. On Monday, 2/23 the rash and swelling was still there and the pain had increased to a level 10. I went to Urgent Care after work. Had an infection and an allergic reaction to shot. Given an antibiotic (Dicloxacillin).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Very red where shot was administrated. Red rash began spreading down arm and arm hurt. The next day Saturday, 2/21 the rash began spreading even more and arm began swelling. On Sunday, 2/22 there was less pain but the rash was still very red and spreading. On Monday, 2/23 the rash and swelling was still there and the pain had increased to a level 10. I went to Urgent Care after work. Had an infection and an allergic reaction to shot. Given an antibiotic (Dicloxacillin).
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Itching on arms, development of rash.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Body aches, redness, swelling, itching, and soreness on left arm(injection site). Then, a blister appeared about 12 hours after. That night(5/02/2015), I had a fever, chills and body aches.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Body aches, redness, swelling, itching, and soreness on left arm(injection site). Then, a blister appeared about 12 hours after. That night(5/02/2015), I had a fever, chills and body aches.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Acute kidney injury, Chemotherapy, Febrile neutropenia, Lymphocyte count decreased, Lymphopenia
Clinical narrative: Information has been received from a published literature article. The patient in this case was a 3 year-old girl with hepatoblastoma. She also had a genetic condition, known as mosaic trisomy 17. Of note, she received varicella vaccine (manufacturer unknown, lot #, dose and route were not reported) when she was 13 months old; however, her screening Varicella-Zoster Virus (VZV)-specific IgG/IgM (ELISA) titers were undetectable when she developed varicella at age 3 years. We defined the day when she developed fever and became critically ill as Day 1. About 1 month prior to this febrile episode, she had been diagnosed with an undifferentiated hepatoblastoma. During her initial chemotherapy regimen, she developed acute kidney injury and a low white blood cell count. She was treated with granulocyte colony stimulation factor. Subsequently, the regimen was switched to vincristine, cisplatin, and doxorubicin, leading to a persistent lymphocytopenia (less than 1000 count/mm2). After she developed fever with neutropenia, she was admitted on day 1 for treatment with antibiotics as per protocol. On Day 2, she developed a vesicular rash on the legs. When VZV antigen was identified by immunostaining cells from a vesicle, she was started on intravenous acyclovir (50 mg/kg/day). Despite treatment, the rash worsened and spread over the next 5 days onto the lower abdomen (the rash, even at onset, never had a zosteriform distribution). The diagnosis of VZV infection was confirmed by polymerase chain reaction (PCR) analysis from deoxyribonucleic acid (DNA) extracted from peripheral white blood cells collected on Day 3. Testing was performed on blood cells to document a persistent viremia while on antiviral therapy. The strain was confirmed as wild type VZV. Fevers continued for 5 days. She finally defervesced with no new lesions on Day 8. Overall, a prolonged course of intravenous acyclovir was continued until Day 19, followed by oral acyclovir (70 mg/kg/day) as suppression therapy for 3 months. Suppressive therapy was lengthy because of a previous case report of recurrence of breakthrough disease in a cancer patient when antiviral therapy was halted too quickly. The source of the VZV infection was never identified. The authors considered the event to be vaccination failure and to be life-threatening. This is one of 2 reports received from the same literature (other case # 1505USA000487). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Pyrexia, Rash, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received from a published literature article. The patient in this case was a 3 year-old girl with hepatoblastoma. She also had a genetic condition, known as mosaic trisomy 17. Of note, she received varicella vaccine (manufacturer unknown, lot #, dose and route were not reported) when she was 13 months old; however, her screening Varicella-Zoster Virus (VZV)-specific IgG/IgM (ELISA) titers were undetectable when she developed varicella at age 3 years. We defined the day when she developed fever and became critically ill as Day 1. About 1 month prior to this febrile episode, she had been diagnosed with an undifferentiated hepatoblastoma. During her initial chemotherapy regimen, she developed acute kidney injury and a low white blood cell count. She was treated with granulocyte colony stimulation factor. Subsequently, the regimen was switched to vincristine, cisplatin, and doxorubicin, leading to a persistent lymphocytopenia (less than 1000 count/mm2). After she developed fever with neutropenia, she was admitted on day 1 for treatment with antibiotics as per protocol. On Day 2, she developed a vesicular rash on the legs. When VZV antigen was identified by immunostaining cells from a vesicle, she was started on intravenous acyclovir (50 mg/kg/day). Despite treatment, the rash worsened and spread over the next 5 days onto the lower abdomen (the rash, even at onset, never had a zosteriform distribution). The diagnosis of VZV infection was confirmed by polymerase chain reaction (PCR) analysis from deoxyribonucleic acid (DNA) extracted from peripheral white blood cells collected on Day 3. Testing was performed on blood cells to document a persistent viremia while on antiviral therapy. The strain was confirmed as wild type VZV. Fevers continued for 5 days. She finally defervesced with no new lesions on Day 8. Overall, a prolonged course of intravenous acyclovir was continued until Day 19, followed by oral acyclovir (70 mg/kg/day) as suppression therapy for 3 months. Suppressive therapy was lengthy because of a previous case report of recurrence of breakthrough disease in a cancer patient when antiviral therapy was halted too quickly. The source of the VZV infection was never identified. The authors considered the event to be vaccination failure and to be life-threatening. This is one of 2 reports received from the same literature (other case # 1505USA000487). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive, Viraemia
Clinical narrative: Information has been received from a published literature article. The patient in this case was a 3 year-old girl with hepatoblastoma. She also had a genetic condition, known as mosaic trisomy 17. Of note, she received varicella vaccine (manufacturer unknown, lot #, dose and route were not reported) when she was 13 months old; however, her screening Varicella-Zoster Virus (VZV)-specific IgG/IgM (ELISA) titers were undetectable when she developed varicella at age 3 years. We defined the day when she developed fever and became critically ill as Day 1. About 1 month prior to this febrile episode, she had been diagnosed with an undifferentiated hepatoblastoma. During her initial chemotherapy regimen, she developed acute kidney injury and a low white blood cell count. She was treated with granulocyte colony stimulation factor. Subsequently, the regimen was switched to vincristine, cisplatin, and doxorubicin, leading to a persistent lymphocytopenia (less than 1000 count/mm2). After she developed fever with neutropenia, she was admitted on day 1 for treatment with antibiotics as per protocol. On Day 2, she developed a vesicular rash on the legs. When VZV antigen was identified by immunostaining cells from a vesicle, she was started on intravenous acyclovir (50 mg/kg/day). Despite treatment, the rash worsened and spread over the next 5 days onto the lower abdomen (the rash, even at onset, never had a zosteriform distribution). The diagnosis of VZV infection was confirmed by polymerase chain reaction (PCR) analysis from deoxyribonucleic acid (DNA) extracted from peripheral white blood cells collected on Day 3. Testing was performed on blood cells to document a persistent viremia while on antiviral therapy. The strain was confirmed as wild type VZV. Fevers continued for 5 days. She finally defervesced with no new lesions on Day 8. Overall, a prolonged course of intravenous acyclovir was continued until Day 19, followed by oral acyclovir (70 mg/kg/day) as suppression therapy for 3 months. Suppressive therapy was lengthy because of a previous case report of recurrence of breakthrough disease in a cancer patient when antiviral therapy was halted too quickly. The source of the VZV infection was never identified. The authors considered the event to be vaccination failure and to be life-threatening. This is one of 2 reports received from the same literature (other case # 1505USA000487). Additional information has been requested.