chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister rupture
Clinical narrative: 2 Blisters developed. Contents were clear fluid only which were drained upon rupture intentionally performed by patient. Blister formed once more, drained, and did not return. Area appears to be healing post-rupture 5 days in.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Arm was sore and red after vaccine on first day. Patient reports that arm is now hot to touch but soreness has gone away.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm was sore and red after vaccine on first day. Patient reports that arm is now hot to touch but soreness has gone away.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Muscle fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: 10 cm very sore, red, swollen region around vaccination site. Started 6 hours after injection, was fully swollen at 24 hours, and continued very sore and swollen for 48 hours. After 80 hours, swelling and redness mostly dissipated, but arm is still sore. Also experienced general muscle fatigue especially in legs for first 48 hours. Took 600 mg Ibuprofen before bedtime for two days to reduce pain.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Mouth swelling, Swelling face, Urticaria
Clinical narrative: Patient called pharmacy on Tuesday, 11/13 stating that starting on Monday night she had hives all over her body. Her mouth and chin were also swollen. She took some allergy medication, which helped but she still had symptoms present in the morning. I directed her to go to her MD to get treatment. She went to emergency room, under the care of Dr., where she got PEPCID, BENADRYL and an EPIPEN.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Area of injection site is red in color 2 x 3 inch, and warm. This started 24 hours after injection felt very malaised, the redness and warmth occurred 48 hours post injection. I suggested that the patient begin with some diphenhydramine tonight at bedtime and apply some ice to the injection site.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient called to express concern over pain at the injection site 7 days post injection. She said the area around the injection site was red, swollen, itching and was spreading to a rash on her chest.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient called to express concern over pain at the injection site 7 days post injection. She said the area around the injection site was red, swollen, itching and was spreading to a rash on her chest.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Eye pain, Neck pain, Pain in extremity
Clinical narrative: Patient said 9 hours after administration she experienced fever (101.0 F), chills, joint, neck and eye pain. Said arm hurt for 48 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient said 9 hours after administration she experienced fever (101.0 F), chills, joint, neck and eye pain. Said arm hurt for 48 hours.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: Shortness of breath, fast heart rate, dizziness, headache, tiredness. This lasted for 24 hours. Five days later, tingling and pain to hands and fingers, extremities.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Shortness of breath, fast heart rate, dizziness, headache, tiredness. This lasted for 24 hours. Five days later, tingling and pain to hands and fingers, extremities.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema
Clinical narrative: Patient called to pharmacy about 40 mins after vaccination complaining that she felt her throat swelling a little about 20 mins after the injection. Advised patient to take BENADRYL or go to the ER if symptoms worsened.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain, including sharp stabbing sensations on hand; severe headache confined to the left side near the ear; fever; fatigue Lasing for 3 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient came back to pharmacy following day (today) 11-13-2018 and showed me a red, painful area that emerged from site of injection down to her elbow area. Warm to touch and slightly hard, though hard to differentiate from normal. she stated it had gotten better since the day before.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient developed spreading redness at injection site. She went to PCP clinic and was prescribed doxycycline 100mg twice daily x 10 days.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Site injections swelling, redness, warmth and hardness. Extreme fatigue lasting approximately 48 hours.
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Unevaluable event
Clinical narrative: (Please refer to 2 page chronological listing of events post immunization provided by patient).
Age: 49.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Amnesia, Antinuclear antibody positive, Dementia, Dementia Alzheimer's type, Impaired work ability
Clinical narrative: After two months from the vaccines and flu shot she started losing her memory very fast, she got diagnosed with Lupus. She started losing her memory faster she couldn't maintain keeping a job. She eventually tested positive for Alzheimer's and dementia. Had to get hospitalized multiple times and now has to live at a nursing home.
Age: 49.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: After two months from the vaccines and flu shot she started losing her memory very fast, she got diagnosed with Lupus. She started losing her memory faster she couldn't maintain keeping a job. She eventually tested positive for Alzheimer's and dementia. Had to get hospitalized multiple times and now has to live at a nursing home.
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site movement impairment, Injection site pain
Clinical narrative: Bled a lot. Bruise the size of softball x 3 weeks. Pain and limited mobility of right arm/shoulder.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hypersomnia
Clinical narrative: Tired, slept 24 hours, diarrhea, chills, headache, painful injection site with swelling.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Tired, slept 24 hours, diarrhea, chills, headache, painful injection site with swelling.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Next day resulted in localized redness, swelling, and sore arm. Has also started itching. Symptoms continued until at least 11-12-18.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site pain, Musculoskeletal stiffness
Clinical narrative: My shoulder was very stiff and I could barely move it that night. The next day it was just sore. The days that followed, the soreness never went away and I felt pain if I moved my shoulder in certain ways, i.e. when pulling a shirt off over my head or swinging a sweater or jacket around my body to put it on. I went to see my doctor about 6 weeks later and she suggested 'wall crawls' and 'pendulum swings' to stretch out my shoulder. I tried to continue my weights routine at my gym, but any weight exercises done with my left arm left it sore and in pain most of the time. It has currently been about 7 weeks since I was given the vaccine and I am still having the same symptoms.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dizziness, Fatigue, Head discomfort, Hyperarousal
Clinical narrative: DAILY DIZZINESS/ VERTIGO; RANDOM AND SPORADIC EPISODES OF FEELINGS OF "FIGHT/FLIGHT", CHEST AND HEAD PRESSURE, TINGLING ALL OVER, PALPITATIONS, BLURRED/ DIMINISHED VISION (VERY BRIEF), TIGHTNESS FEELING IN THROAT, (NONE OF THE ABOVE SENSATIONS INCLUDED ANY PAIN). DAILY DIZZINESS/ VERTIGO WAS TREATED WITH NON-DROWSY DRAMAMINE (WHILE AT WORK), AND MECLIZINE (PRESCRIBED BY MD) WHICH I HAVE NOT USED YET. DRAMAMINE WAS EFFECTIVE MOST OF THE TIME. SYMPTOMS WHICH I HAD WITHIN THE FIRST WEEK AFTER ADMINISTRATION WHICH HAVE SINCE RESOLVED: FATIGUE, MYALGIA (AT INJECTION SITE); ANERGIA.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Palpitations, Paraesthesia, Throat tightness, Vertigo
Clinical narrative: DAILY DIZZINESS/ VERTIGO; RANDOM AND SPORADIC EPISODES OF FEELINGS OF "FIGHT/FLIGHT", CHEST AND HEAD PRESSURE, TINGLING ALL OVER, PALPITATIONS, BLURRED/ DIMINISHED VISION (VERY BRIEF), TIGHTNESS FEELING IN THROAT, (NONE OF THE ABOVE SENSATIONS INCLUDED ANY PAIN). DAILY DIZZINESS/ VERTIGO WAS TREATED WITH NON-DROWSY DRAMAMINE (WHILE AT WORK), AND MECLIZINE (PRESCRIBED BY MD) WHICH I HAVE NOT USED YET. DRAMAMINE WAS EFFECTIVE MOST OF THE TIME. SYMPTOMS WHICH I HAD WITHIN THE FIRST WEEK AFTER ADMINISTRATION WHICH HAVE SINCE RESOLVED: FATIGUE, MYALGIA (AT INJECTION SITE); ANERGIA.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vision blurred, Visual impairment
Clinical narrative: DAILY DIZZINESS/ VERTIGO; RANDOM AND SPORADIC EPISODES OF FEELINGS OF "FIGHT/FLIGHT", CHEST AND HEAD PRESSURE, TINGLING ALL OVER, PALPITATIONS, BLURRED/ DIMINISHED VISION (VERY BRIEF), TIGHTNESS FEELING IN THROAT, (NONE OF THE ABOVE SENSATIONS INCLUDED ANY PAIN). DAILY DIZZINESS/ VERTIGO WAS TREATED WITH NON-DROWSY DRAMAMINE (WHILE AT WORK), AND MECLIZINE (PRESCRIBED BY MD) WHICH I HAVE NOT USED YET. DRAMAMINE WAS EFFECTIVE MOST OF THE TIME. SYMPTOMS WHICH I HAD WITHIN THE FIRST WEEK AFTER ADMINISTRATION WHICH HAVE SINCE RESOLVED: FATIGUE, MYALGIA (AT INJECTION SITE); ANERGIA.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness
Clinical narrative: DAILY DIZZINESS/ VERTIGO; RANDOM AND SPORADIC EPISODES OF FEELINGS OF "FIGHT/FLIGHT", CHEST AND HEAD PRESSURE, TINGLING ALL OVER, PALPITATIONS, BLURRED/ DIMINISHED VISION (VERY BRIEF), TIGHTNESS FEELING IN THROAT, (NONE OF THE ABOVE SENSATIONS INCLUDED ANY PAIN). DAILY DIZZINESS/ VERTIGO WAS TREATED WITH NON-DROWSY DRAMAMINE (WHILE AT WORK), AND MECLIZINE (PRESCRIBED BY MD) WHICH I HAVE NOT USED YET. DRAMAMINE WAS EFFECTIVE MOST OF THE TIME. SYMPTOMS WHICH I HAD WITHIN THE FIRST WEEK AFTER ADMINISTRATION WHICH HAVE SINCE RESOLVED: FATIGUE, MYALGIA (AT INJECTION SITE); ANERGIA.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dysphonia, Lethargy, Malaise, Pyrexia
Clinical narrative: Per Mother's call today requesting a VAERS be filed: apparently the afternoon of vaccines she developed a fever greater than 102 persistent x8 days (somewhat responsive to TYLENOL), lethargic, high pitched squeaks rather than babbles and acting unwell x8days. Didn't seem to return to normal, especially regarding communications for several wks. Mom concerned given she has a sibling with autism and will refuse further vaccines so no need for well visits given her busy schedule in nursing school she feels. Did not have child evaluated during reaction feeling would simply be told to do sx treatment. Encouraged to come for eval, has not been seen since this visit.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Injection site swelling, Pain
Clinical narrative: I had this vaccine about 4:30 pm on 11/11/18. On 11/12/18 around 8:00am, I experienced chills and sweats. I checked my temperature with a thermometer around 11:30am and it was 101.2 F. I took ibuprofen to help reduce the fever, and I also experienced body aches and extreme pain, swelling (but no redness) at the injection site. The fever and body aches seemed to resolve about 4:00am on 11/13/18, although the swelling and pain at the injection site has only slightly improved.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I had this vaccine about 4:30 pm on 11/11/18. On 11/12/18 around 8:00am, I experienced chills and sweats. I checked my temperature with a thermometer around 11:30am and it was 101.2 F. I took ibuprofen to help reduce the fever, and I also experienced body aches and extreme pain, swelling (but no redness) at the injection site. The fever and body aches seemed to resolve about 4:00am on 11/13/18, although the swelling and pain at the injection site has only slightly improved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram retina, Anti-aquaporin-4 antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blindness unilateral
Clinical narrative: 4/25/18 - 1st shot of SHINGRIX vaccine. Sick for 2 days with muscle pain, fatigue, nausea, headache, shivering, chills. 9/11/18 - 2nd shot of SHINGRIX. Sick for 4 days with the same symptoms, only more severe. 9/27/18 - Woke up with right eye vision loss. Had an appointment to pick up contacts so Dr. did a full eye exam. Could only see the top of the big E. Had a visual field test 9/28/18 - Saw Dr. in ophthalmology. Diagnosed ION, although I don't have any of the normal risk factors of diabetes, hypertension, or sleep apnea. 10/7/18 - Experiencing the same symptoms as right after the shots, chills, headache, dizziness, muscle aches and fatigue. Dr. had me come to ER for the MRIs that night 10/8/18 - Saw Dr.  I couldn't see his hand with my right eye 2 inches from my face. Had visual field test. Saw Dr (retina specialist). He gave me a shot of Avastin. 10/10/18 - Started on 60 mg of Prednisone 10/17/18 - Saw Dr. at the Eye Institute. Showed him article. Dr. found 3 other cases like mine of ION in the trials. See Testimony on SHINGRIX dated September 13, 2017. 10/18/18, 10/19/18, 10/20/18 - infusions of 1000 mg of Prednisone 10/21/18 - back on 60 mg Prednisone Diagnosis:  Edema of optic disc of right eye, Ischemic optic neuropathy of right eye, Macular retinal edema, Nuclear sclerosis of both eyes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia test, C-reactive protein, Cardiolipin antibody, Cataract nuclear, Chills
Clinical narrative: 4/25/18 - 1st shot of SHINGRIX vaccine. Sick for 2 days with muscle pain, fatigue, nausea, headache, shivering, chills. 9/11/18 - 2nd shot of SHINGRIX. Sick for 4 days with the same symptoms, only more severe. 9/27/18 - Woke up with right eye vision loss. Had an appointment to pick up contacts so Dr. did a full eye exam. Could only see the top of the big E. Had a visual field test 9/28/18 - Saw Dr. in ophthalmology. Diagnosed ION, although I don't have any of the normal risk factors of diabetes, hypertension, or sleep apnea. 10/7/18 - Experiencing the same symptoms as right after the shots, chills, headache, dizziness, muscle aches and fatigue. Dr. had me come to ER for the MRIs that night 10/8/18 - Saw Dr.  I couldn't see his hand with my right eye 2 inches from my face. Had visual field test. Saw Dr (retina specialist). He gave me a shot of Avastin. 10/10/18 - Started on 60 mg of Prednisone 10/17/18 - Saw Dr. at the Eye Institute. Showed him article. Dr. found 3 other cases like mine of ION in the trials. See Testimony on SHINGRIX dated September 13, 2017. 10/18/18, 10/19/18, 10/20/18 - infusions of 1000 mg of Prednisone 10/21/18 - back on 60 mg Prednisone Diagnosis:  Edema of optic disc of right eye, Ischemic optic neuropathy of right eye, Macular retinal edema, Nuclear sclerosis of both eyes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Coagulation test, Differential white blood cell count, Dizziness, Fatigue, Full blood count
Clinical narrative: 4/25/18 - 1st shot of SHINGRIX vaccine. Sick for 2 days with muscle pain, fatigue, nausea, headache, shivering, chills. 9/11/18 - 2nd shot of SHINGRIX. Sick for 4 days with the same symptoms, only more severe. 9/27/18 - Woke up with right eye vision loss. Had an appointment to pick up contacts so Dr. did a full eye exam. Could only see the top of the big E. Had a visual field test 9/28/18 - Saw Dr. in ophthalmology. Diagnosed ION, although I don't have any of the normal risk factors of diabetes, hypertension, or sleep apnea. 10/7/18 - Experiencing the same symptoms as right after the shots, chills, headache, dizziness, muscle aches and fatigue. Dr. had me come to ER for the MRIs that night 10/8/18 - Saw Dr.  I couldn't see his hand with my right eye 2 inches from my face. Had visual field test. Saw Dr (retina specialist). He gave me a shot of Avastin. 10/10/18 - Started on 60 mg of Prednisone 10/17/18 - Saw Dr. at the Eye Institute. Showed him article. Dr. found 3 other cases like mine of ION in the trials. See Testimony on SHINGRIX dated September 13, 2017. 10/18/18, 10/19/18, 10/20/18 - infusions of 1000 mg of Prednisone 10/21/18 - back on 60 mg Prednisone Diagnosis:  Edema of optic disc of right eye, Ischemic optic neuropathy of right eye, Macular retinal edema, Nuclear sclerosis of both eyes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fundoscopy, Headache, Immunology test, Laboratory test, Lipids
Clinical narrative: 4/25/18 - 1st shot of SHINGRIX vaccine. Sick for 2 days with muscle pain, fatigue, nausea, headache, shivering, chills. 9/11/18 - 2nd shot of SHINGRIX. Sick for 4 days with the same symptoms, only more severe. 9/27/18 - Woke up with right eye vision loss. Had an appointment to pick up contacts so Dr. did a full eye exam. Could only see the top of the big E. Had a visual field test 9/28/18 - Saw Dr. in ophthalmology. Diagnosed ION, although I don't have any of the normal risk factors of diabetes, hypertension, or sleep apnea. 10/7/18 - Experiencing the same symptoms as right after the shots, chills, headache, dizziness, muscle aches and fatigue. Dr. had me come to ER for the MRIs that night 10/8/18 - Saw Dr.  I couldn't see his hand with my right eye 2 inches from my face. Had visual field test. Saw Dr (retina specialist). He gave me a shot of Avastin. 10/10/18 - Started on 60 mg of Prednisone 10/17/18 - Saw Dr. at the Eye Institute. Showed him article. Dr. found 3 other cases like mine of ION in the trials. See Testimony on SHINGRIX dated September 13, 2017. 10/18/18, 10/19/18, 10/20/18 - infusions of 1000 mg of Prednisone 10/21/18 - back on 60 mg Prednisone Diagnosis:  Edema of optic disc of right eye, Ischemic optic neuropathy of right eye, Macular retinal edema, Nuclear sclerosis of both eyes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Metabolic function test, Myalgia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: 4/25/18 - 1st shot of SHINGRIX vaccine. Sick for 2 days with muscle pain, fatigue, nausea, headache, shivering, chills. 9/11/18 - 2nd shot of SHINGRIX. Sick for 4 days with the same symptoms, only more severe. 9/27/18 - Woke up with right eye vision loss. Had an appointment to pick up contacts so Dr. did a full eye exam. Could only see the top of the big E. Had a visual field test 9/28/18 - Saw Dr. in ophthalmology. Diagnosed ION, although I don't have any of the normal risk factors of diabetes, hypertension, or sleep apnea. 10/7/18 - Experiencing the same symptoms as right after the shots, chills, headache, dizziness, muscle aches and fatigue. Dr. had me come to ER for the MRIs that night 10/8/18 - Saw Dr.  I couldn't see his hand with my right eye 2 inches from my face. Had visual field test. Saw Dr (retina specialist). He gave me a shot of Avastin. 10/10/18 - Started on 60 mg of Prednisone 10/17/18 - Saw Dr. at the Eye Institute. Showed him article. Dr. found 3 other cases like mine of ION in the trials. See Testimony on SHINGRIX dated September 13, 2017. 10/18/18, 10/19/18, 10/20/18 - infusions of 1000 mg of Prednisone 10/21/18 - back on 60 mg Prednisone Diagnosis:  Edema of optic disc of right eye, Ischemic optic neuropathy of right eye, Macular retinal edema, Nuclear sclerosis of both eyes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmological examination abnormal, Optic ischaemic neuropathy, Optical coherence tomography, Papilloedema, Red blood cell sedimentation rate
Clinical narrative: 4/25/18 - 1st shot of SHINGRIX vaccine. Sick for 2 days with muscle pain, fatigue, nausea, headache, shivering, chills. 9/11/18 - 2nd shot of SHINGRIX. Sick for 4 days with the same symptoms, only more severe. 9/27/18 - Woke up with right eye vision loss. Had an appointment to pick up contacts so Dr. did a full eye exam. Could only see the top of the big E. Had a visual field test 9/28/18 - Saw Dr. in ophthalmology. Diagnosed ION, although I don't have any of the normal risk factors of diabetes, hypertension, or sleep apnea. 10/7/18 - Experiencing the same symptoms as right after the shots, chills, headache, dizziness, muscle aches and fatigue. Dr. had me come to ER for the MRIs that night 10/8/18 - Saw Dr.  I couldn't see his hand with my right eye 2 inches from my face. Had visual field test. Saw Dr (retina specialist). He gave me a shot of Avastin. 10/10/18 - Started on 60 mg of Prednisone 10/17/18 - Saw Dr. at the Eye Institute. Showed him article. Dr. found 3 other cases like mine of ION in the trials. See Testimony on SHINGRIX dated September 13, 2017. 10/18/18, 10/19/18, 10/20/18 - infusions of 1000 mg of Prednisone 10/21/18 - back on 60 mg Prednisone Diagnosis:  Edema of optic disc of right eye, Ischemic optic neuropathy of right eye, Macular retinal edema, Nuclear sclerosis of both eyes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Retinal oedema, Scan with contrast, Treponema test, Ultrasound Doppler, Visual field tests abnormal
Clinical narrative: 4/25/18 - 1st shot of SHINGRIX vaccine. Sick for 2 days with muscle pain, fatigue, nausea, headache, shivering, chills. 9/11/18 - 2nd shot of SHINGRIX. Sick for 4 days with the same symptoms, only more severe. 9/27/18 - Woke up with right eye vision loss. Had an appointment to pick up contacts so Dr. did a full eye exam. Could only see the top of the big E. Had a visual field test 9/28/18 - Saw Dr. in ophthalmology. Diagnosed ION, although I don't have any of the normal risk factors of diabetes, hypertension, or sleep apnea. 10/7/18 - Experiencing the same symptoms as right after the shots, chills, headache, dizziness, muscle aches and fatigue. Dr. had me come to ER for the MRIs that night 10/8/18 - Saw Dr.  I couldn't see his hand with my right eye 2 inches from my face. Had visual field test. Saw Dr (retina specialist). He gave me a shot of Avastin. 10/10/18 - Started on 60 mg of Prednisone 10/17/18 - Saw Dr. at the Eye Institute. Showed him article. Dr. found 3 other cases like mine of ION in the trials. See Testimony on SHINGRIX dated September 13, 2017. 10/18/18, 10/19/18, 10/20/18 - infusions of 1000 mg of Prednisone 10/21/18 - back on 60 mg Prednisone Diagnosis:  Edema of optic disc of right eye, Ischemic optic neuropathy of right eye, Macular retinal edema, Nuclear sclerosis of both eyes.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Pt's mom reported redness at the site of injection. Pharmacist looked at the injection site and mild redness around the injection site was observed.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pruritus, Pyrexia, Rash
Clinical narrative: Fever (101 degree) and muscle aches Rash and itchiness.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reported on Nov 12, 2018 that he has been having a debilitating pain in the left arm ever since he got the flu shot on Sept 17, 2018. He is going to have MRI. Patient reported also having adverse reaction in the past with the flu shot but this one took longer.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Acute myocardial infarction, Angiogram, Angiogram normal, Blood creatine phosphokinase, Blood lactic acid
Clinical narrative: Pt received flu vaccine at work from pharmacy for a health fair. One and a half hours after vaccination, he started to get severe vertigo with nausea and vomiting, along w/profuse diaphoresis. His coworkers called 911 and he was taken to Hospital ER via ambulance. EMT's started code as he had abnormal EKG changes. He was evaluated in ER and multiple tests were completed (see list below). He was admitted from 10/25/18 - 10/27/18 for observation and to complete his stress test and was cleared for discharge after completion. EKG in ambulance showed sinus rhythm with prominent T waves and possible ST elevation which prompted STEMI code by EMS. EKG in ER. Echocardiogram stress test completed both being unremarkable. MRI stroke protocol was negative. CT angiogram of chest to rule out pulmonary embolism was negative.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac stress test, Computerised tomogram head, Computerised tomogram thorax normal, Echocardiogram normal, Electrocardiogram T wave abnormal
Clinical narrative: Pt received flu vaccine at work from pharmacy for a health fair. One and a half hours after vaccination, he started to get severe vertigo with nausea and vomiting, along w/profuse diaphoresis. His coworkers called 911 and he was taken to Hospital ER via ambulance. EMT's started code as he had abnormal EKG changes. He was evaluated in ER and multiple tests were completed (see list below). He was admitted from 10/25/18 - 10/27/18 for observation and to complete his stress test and was cleared for discharge after completion. EKG in ambulance showed sinus rhythm with prominent T waves and possible ST elevation which prompted STEMI code by EMS. EKG in ER. Echocardiogram stress test completed both being unremarkable. MRI stroke protocol was negative. CT angiogram of chest to rule out pulmonary embolism was negative.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram abnormal, Fibrin D dimer, Full blood count, Hyperhidrosis, Metabolic function test
Clinical narrative: Pt received flu vaccine at work from pharmacy for a health fair. One and a half hours after vaccination, he started to get severe vertigo with nausea and vomiting, along w/profuse diaphoresis. His coworkers called 911 and he was taken to Hospital ER via ambulance. EMT's started code as he had abnormal EKG changes. He was evaluated in ER and multiple tests were completed (see list below). He was admitted from 10/25/18 - 10/27/18 for observation and to complete his stress test and was cleared for discharge after completion. EKG in ambulance showed sinus rhythm with prominent T waves and possible ST elevation which prompted STEMI code by EMS. EKG in ER. Echocardiogram stress test completed both being unremarkable. MRI stroke protocol was negative. CT angiogram of chest to rule out pulmonary embolism was negative.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Nuclear magnetic resonance imaging normal, Troponin, Vertigo, Vomiting
Clinical narrative: Pt received flu vaccine at work from pharmacy for a health fair. One and a half hours after vaccination, he started to get severe vertigo with nausea and vomiting, along w/profuse diaphoresis. His coworkers called 911 and he was taken to Hospital ER via ambulance. EMT's started code as he had abnormal EKG changes. He was evaluated in ER and multiple tests were completed (see list below). He was admitted from 10/25/18 - 10/27/18 for observation and to complete his stress test and was cleared for discharge after completion. EKG in ambulance showed sinus rhythm with prominent T waves and possible ST elevation which prompted STEMI code by EMS. EKG in ER. Echocardiogram stress test completed both being unremarkable. MRI stroke protocol was negative. CT angiogram of chest to rule out pulmonary embolism was negative.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Decreased appetite, Fatigue, Hyperhidrosis, Insomnia
Clinical narrative: Hot/cold sweats, fatigue, nervousness, loss of appetite, fear of sleep. Been to ER twice and doctor 1. Say they can't do anything.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Nervousness
Clinical narrative: Hot/cold sweats, fatigue, nervousness, loss of appetite, fear of sleep. Been to ER twice and doctor 1. Say they can't do anything.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Lethargy, Pyrexia
Clinical narrative: Per mom, the day after the flu vaccine (10/30/18) patient developed a fever. It got up to 101.9. Pt was more lethargic too. Symptoms and fever resolved the next day (10/31/18).
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Mass
Clinical narrative: Patient developed a lump the size of thump on shoulder a day after the shot, after that it started to get red and got bigger and bigger and it turned out to be shingles.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Bone pain, Fatigue, Nausea
Clinical narrative: 4 days after vaccine, awoke w/sudden onset of bone pain - mid to low back, hips, thighs, knees, wrists; w/ periodic nausea and fatigue ... is slowly improving on NSAIDs. Now w/ LBP = 5/10.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness
Clinical narrative: Flu shot caused severe dizziness. It is now abating.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chills, Cold sweat, Differential white blood cell count abnormal, Erythema
Clinical narrative: Injection of Pneumococcal Polysaccharide Vaccine 23-Valent IM was given on 11/1/2018. On 11/2/2018, I had a large amount of swelling and red hot areas around the infection site, along with high fever up to 103 (using TYLENOL and Ibuprofen every two hours). The following day, the redness was up and down my entire upper arm. My fever was 104. I was shivering and my teeth were chattering. Despite taking Ibuprofen and TYLENOL I was not able to reduce my fever. The same on Sunday, after beginning Clindamycin. By Monday morning, my fever was a manageable 101 and attempted to return to work. My fever spiked on and off throughout the day. The redness and swelling on my arm was a deep burning sensation. By Tuesday, the fever came and went as did the cold sweating. The pain was still at about an 8. Today is 11/8/18 and the site and swollen areas are an awful purple color and the pain in my arm is still about an 8. The fevers and cold sweats have been alternating throughout the day.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count abnormal, Infection, Injection site discolouration, Injection site swelling, Pain in extremity
Clinical narrative: Injection of Pneumococcal Polysaccharide Vaccine 23-Valent IM was given on 11/1/2018. On 11/2/2018, I had a large amount of swelling and red hot areas around the infection site, along with high fever up to 103 (using TYLENOL and Ibuprofen every two hours). The following day, the redness was up and down my entire upper arm. My fever was 104. I was shivering and my teeth were chattering. Despite taking Ibuprofen and TYLENOL I was not able to reduce my fever. The same on Sunday, after beginning Clindamycin. By Monday morning, my fever was a manageable 101 and attempted to return to work. My fever spiked on and off throughout the day. The redness and swelling on my arm was a deep burning sensation. By Tuesday, the fever came and went as did the cold sweating. The pain was still at about an 8. Today is 11/8/18 and the site and swollen areas are an awful purple color and the pain in my arm is still about an 8. The fevers and cold sweats have been alternating throughout the day.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Swelling
Clinical narrative: Injection of Pneumococcal Polysaccharide Vaccine 23-Valent IM was given on 11/1/2018. On 11/2/2018, I had a large amount of swelling and red hot areas around the infection site, along with high fever up to 103 (using TYLENOL and Ibuprofen every two hours). The following day, the redness was up and down my entire upper arm. My fever was 104. I was shivering and my teeth were chattering. Despite taking Ibuprofen and TYLENOL I was not able to reduce my fever. The same on Sunday, after beginning Clindamycin. By Monday morning, my fever was a manageable 101 and attempted to return to work. My fever spiked on and off throughout the day. The redness and swelling on my arm was a deep burning sensation. By Tuesday, the fever came and went as did the cold sweating. The pain was still at about an 8. Today is 11/8/18 and the site and swollen areas are an awful purple color and the pain in my arm is still about an 8. The fevers and cold sweats have been alternating throughout the day.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Malaise, Pyrexia, Rash macular, Swelling face
Clinical narrative: Patient had fever 24 hours after vaccine. Then 2 and 3 days later had facial swelling and blotchy redness around both eyes, worse around right eye. Pt. also suffered general malaise during this time. All resolved uneventfully without any outside intervention. (Patient's brother had the same symptoms recently after receiving his kindergarten shots at another facility).
Age: 78.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site hypersensitivity
Clinical narrative: Allergy and red in the right deltoid arm. Treatment - BENADRYL 50 mg q 6 hr prn, put ice bag in this area; call in two days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Muscle swelling, Myalgia
Clinical narrative: Patient presented with sore and swollen biceps - marked area and asked to watch for spreading swollen tissues. Will see a provider if it increases in area then will visit MD. Patient returned 11/12 at 9am and swelling and redness had not spread - his arm feels much better.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Pain in left arm, stiff neck on left side and pain, and headaches on the left side.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Pruritus, Skin discolouration
Clinical narrative: Bruised skin, itching and black.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nodule, Ultrasound skull normal
Clinical narrative: Received vaccines on 11/5/18. Since back in office on 11/9/18 with C/O knot on head that came up 24 hrs after vaccines. No injury. Full fontanelle. U/S head on 11/9/18 normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Chills, Pain, Pain in extremity
Clinical narrative: SHINGRIX administered 11/8/18. Woke up early 11/9/18 with back pain, fever, chills and generalized weakness and achiness. Arm was a little sore.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: SHINGRIX administered 11/8/18. Woke up early 11/9/18 with back pain, fever, chills and generalized weakness and achiness. Arm was a little sore.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia, Occult blood positive, Rotavirus test positive
Clinical narrative: Patient presented with blood in stool and several weeks of green, watery stools. Advised to eliminate all dairy from mom's diet for 2 weeks, ordered FOBT and stool sample testing on 11/05/2018. Administered Hemocult lab during the visit and the result was positive. Mom dropped off a stool sample on 11/06/2018 and the sample was sent to Lab for GI Pathogen Panel.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Numbness in whole left arm.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Small itch rash around injection site of MMRV vaccine. Counseled by Dr. Rash resolved in 2 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: About 3" below the injection site 2 days after vaccine had an area about 5" x 3" red and warm to touch. Showed PCP Mon. 10/1/18 (Oct). She wasn't sure if allergic reaction. No temperature. Pain where shot given.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history or concomitant medications. On or about 09-JUN-2015 a healthcare provider at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 21-NOV-2017, the patient was treated by a physician at a healthcare facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Dysgeusia, Fatigue
Clinical narrative: Severe malaise, severe aches, no appetite or ability to drink water.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Severe malaise, severe aches, no appetite or ability to drink water.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Hypophagia, Malaise, Pain
Clinical narrative: Severe malaise, severe aches, no appetite or ability to drink water.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hot flush, Immediate post-injection reaction, Nasopharyngitis, Nausea
Clinical narrative: On 10/19/18 had feeling of paresthesias in the fingertips that gradually ascended up her arms over the next day. This feeling worsened and then involved her legs also over the next few days.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Throat irritation
Clinical narrative: On 10/19/18 had feeling of paresthesias in the fingertips that gradually ascended up her arms over the next day. This feeling worsened and then involved her legs also over the next few days.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Paraesthesia
Clinical narrative: On 10/19/18 had feeling of paresthesias in the fingertips that gradually ascended up her arms over the next day. This feeling worsened and then involved her legs also over the next few days.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ligament disorder, Pain, Pain in extremity, Tendon disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported via web call back. The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient reported that SHINGRIX vaccine side effect was an ongoing issue. No other details were provided. Attempt was made to call the patient back to obtain further details but contact unsuccessful. Reached callers voicemail and left voicemail with phone number, hours of operation and case number.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ligament pain, Neuralgia, Pain in extremity, Tendon pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported via web call back. The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient reported that SHINGRIX vaccine side effect was an ongoing issue. No other details were provided. Attempt was made to call the patient back to obtain further details but contact unsuccessful. Reached callers voicemail and left voicemail with phone number, hours of operation and case number.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported via web call back. The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient reported that SHINGRIX vaccine side effect was an ongoing issue. No other details were provided. Attempt was made to call the patient back to obtain further details but contact unsuccessful. Reached callers voicemail and left voicemail with phone number, hours of operation and case number.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Neck pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Concomitant products included SHINGRIX. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling. On 24th October 2018, 1 day after receiving SHINGRIX, the patient experienced headache, fever, injection site swelling, neck pain and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, fever, local swelling, injection site swelling, neck pain and pain in arm were unknown. It was unknown if the reporter considered the headache, fever, local swelling, injection site swelling, neck pain and pain in arm to be related to SHINGRIX. Additional information was provided as follows: This case was reported by the patient's daughter. The patient received SHINGRIX in the left arm. The patient experienced adverse events with both doses of SHINGRIX. After receiving SHINGRIX, the patient experienced fever of 99.2 degree F, arm pain, swelling at injection site, headache, and neck pain. All of these events were noted to be worse on 25th October 2018. The patient's daughter also noticed a bump on patient's head, that the mother denied any type of fall or injury. The pharmacist reported that she encouraged an emergency room visit for the bump on the head because the prescribing information did not mention this as a side effect. This case has been linked with case US2018GSK205413, reported by same reporter for same patient.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Concomitant products included SHINGRIX. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling. On 24th October 2018, 1 day after receiving SHINGRIX, the patient experienced headache, fever, injection site swelling, neck pain and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, fever, local swelling, injection site swelling, neck pain and pain in arm were unknown. It was unknown if the reporter considered the headache, fever, local swelling, injection site swelling, neck pain and pain in arm to be related to SHINGRIX. Additional information was provided as follows: This case was reported by the patient's daughter. The patient received SHINGRIX in the left arm. The patient experienced adverse events with both doses of SHINGRIX. After receiving SHINGRIX, the patient experienced fever of 99.2 degree F, arm pain, swelling at injection site, headache, and neck pain. All of these events were noted to be worse on 25th October 2018. The patient's daughter also noticed a bump on patient's head, that the mother denied any type of fall or injury. The pharmacist reported that she encouraged an emergency room visit for the bump on the head because the prescribing information did not mention this as a side effect. This case has been linked with case US2018GSK205413, reported by same reporter for same patient.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site swelling, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Concomitant products included SHINGRIX. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling. On 24th October 2018, 1 day after receiving SHINGRIX, the patient experienced headache, fever, injection site swelling, neck pain and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, fever, local swelling, injection site swelling, neck pain and pain in arm were unknown. It was unknown if the reporter considered the headache, fever, local swelling, injection site swelling, neck pain and pain in arm to be related to SHINGRIX. Additional information was provided as follows: This case was reported by the patient's daughter. The patient received SHINGRIX in the left arm. The patient experienced adverse events with both doses of SHINGRIX. After receiving SHINGRIX, the patient experienced fever of 99.2 degree F, arm pain, swelling at injection site, headache, and neck pain. All of these events were noted to be worse on 25th October 2018. The patient's daughter also noticed a bump on patient's head, that the mother denied any type of fall or injury. The pharmacist reported that she encouraged an emergency room visit for the bump on the head because the prescribing information did not mention this as a side effect. This case has been linked with case US2018GSK205413, reported by same reporter for same patient.