chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Central nervous system lesion, Foreign travel, Full blood count normal, Hypoaesthesia, Inflammation
Clinical narrative: Symptoms of leg numbness, radiating down legs, started before 7/22/18 but not reported until he traveled out of the country with father and reported to us on 7/22/18. While abroad, he saw neurologist and was admitted for MRI of spine on July 24. Neurologist thought he had an underlying condition possibly muscular sclerosis with concurrent inflammatory new process because the MRI showed old and new lesions. He was considered stable and returned home on Saturday 8/28/18. On 8/29/18, he complained of blurring of vision and was taken to their nearest ED, and he was admitted.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Laboratory test normal, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Vision blurred
Clinical narrative: Symptoms of leg numbness, radiating down legs, started before 7/22/18 but not reported until he traveled out of the country with father and reported to us on 7/22/18. While abroad, he saw neurologist and was admitted for MRI of spine on July 24. Neurologist thought he had an underlying condition possibly muscular sclerosis with concurrent inflammatory new process because the MRI showed old and new lesions. He was considered stable and returned home on Saturday 8/28/18. On 8/29/18, he complained of blurring of vision and was taken to their nearest ED, and he was admitted.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pruritus
Clinical narrative: Around 8 hours after the shot, I developed a line of blisters about an inch long. It is very itchy. The blisters are still there and fluid inside and still very itchy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Gait disturbance, Headache, Malaise, Myalgia
Clinical narrative: This is the second part of SHINGRIX. I received the vaccine at 5pm approximately, and by 9pm I was having malaise all over my body and my arm hurt. I went to bed and woke up worse. The muscles in my body hurt to the point that I walking a little bit slow. I also felt feverish but did not take temp. I took acetaminophen 500mg by 6:30PM and went to work. At work the pain continue and I felt very cold. I took another acetaminophen 325mg by 10AM. At 1:30PM I left work because I continue to feel body ache, fever and headache. I took acetaminophen 500mg at 2. Now, at 4PM I took my temp and it was 99.2F. Still feeling sick.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This is the second part of SHINGRIX. I received the vaccine at 5pm approximately, and by 9pm I was having malaise all over my body and my arm hurt. I went to bed and woke up worse. The muscles in my body hurt to the point that I walking a little bit slow. I also felt feverish but did not take temp. I took acetaminophen 500mg by 6:30PM and went to work. At work the pain continue and I felt very cold. I took another acetaminophen 325mg by 10AM. At 1:30PM I left work because I continue to feel body ache, fever and headache. I took acetaminophen 500mg at 2. Now, at 4PM I took my temp and it was 99.2F. Still feeling sick.
Age: 67.0
Sex: M
Vaccine: VARZOS, FLU4
Symptoms: Feeling hot, Injection site pain, Night sweats
Clinical narrative: Night sweats, extreme soreness at injection site, hot spells (last 3 days after injection).
Age: 67.0
Sex: M
Vaccine: VARZOS, FLU4
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia
Clinical narrative: Night sweats, extreme soreness at injection site, hot spells (last 3 days after injection).
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt had syncopal episode after receiving vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The evening after receiving her BEXSERO number 1 she started to get a red mark around the injection sight, by Saturday it was 3 inches, warm to touch, painful, then today it was 1 and 1/4 inches. She's had a headache since then.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Patient came in to the pharmacy on Monday, 3 days after vaccination, presenting with a red skin rash around the injection site. She stated that the area began itching Sunday and felt warm to touch. As of Monday, the itching had subsided some, but was still warm to the touch. She was instructed to use some Hydrocortisone cream for the itching. Upon speaking to the patient on Tuesday afternoon, she stated the rash has begun to lighten and the itching has almost gone away.
Age: 21.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Immunisation, Underdose
Clinical narrative: Patient was given Pediatric dose of Hep B. Patient was revaccinated at a later date with Adult dose of Hep B.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Pyrexia
Clinical narrative: Fever X 4 days/passed out.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced chills, severe pain and swelling in her left arm and pain in her joints. The area was warm to touch but was not red. The patient was unable to fully lift arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Patient experienced chills, severe pain and swelling in her left arm and pain in her joints. The area was warm to touch but was not red. The patient was unable to fully lift arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site hypersensitivity, Vaccination complication
Clinical narrative: Pt called the pharmacy saying that she had to go ER with a severe allergic reaction in the injection site that spread to all over her body, was told by health care provioders there thats its reaction to the vaccine and was advised to report to the pharmacy, been taking BENADRYL.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm with severe swelling from elbow up, hot to touch, severe pain still present 24 hrs later.
Age: 15.0
Sex: F
Vaccine: HPV9, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 15-year-old female brought in by mother presents to the clinic today for redness on arm. Mother states that the patient received the varicella vaccine yesterday. After vaccine, pt developed an area of redness and tenderness around injection site so mother decided to bring pt back to the clinic for medical evaluation. Denies previous hx of vaccine reactions. Denies f/c/ns, n/v, trouble breathing, SOB, CP. No other concerns.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Pt received varicella vaccine. Pt sitting on Dads lab when Nurse walked out of room. Dad came out of room stating patient passed out and hit head on counter then floor. Patient placed on table. Pt examined by CRNP. B/P WNL. Pulse ox 99%. Pt left office in stable condition after waiting 20 mins and being examined by CRNP.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt. had major swelling of left arm, warmth to touch, red, severe arm pain that kept her up all night and is still bothering her.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Conjunctivitis, Cough, Immunology test, Laboratory test normal, Measles
Clinical narrative: Full -blown presentation of measles w/ severe conjunctivitis, coryza, rhinorrhea, cough, OM and fever followed by typical rash. Treatment was supportive w/ workup for immunodeficiency and referral to immunologist.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Otitis media, Pyrexia, Rash, Rhinitis, Rhinorrhoea
Clinical narrative: Full -blown presentation of measles w/ severe conjunctivitis, coryza, rhinorrhea, cough, OM and fever followed by typical rash. Treatment was supportive w/ workup for immunodeficiency and referral to immunologist.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: 4 hrs after getting pneumonia injection right arm -swelled to twice the size, pain was excruciating x 3 days.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Head injury, Syncope
Clinical narrative: Patient received second vaccine, Hepatitis A, in right arm. He was sitting in chair and had stated that he was "okay" after injection. When patient turned in chair to get up, he experienced syncope. Patient slowly leaned forward and bumped his head on the side of the bed. A nurse was able to assist patient to lean back on the chair. Parents declined cold compress for head. No injuries noted and patient stated that he was fine. Monitored patient for 30 minutes and obtained blood pressures with heart rates. Patient stayed in clinic for an hour overall while waiting for siblings to get vaccinations. Patient able to ambulate with a steady gait to car.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: 12/31/2016 initial tingling in feet. 1/1/2017 unable to walk steady, used a cane, went to emergency room at hospital. Sent home. 1/4/2017 saw Dr. at Clinic, walking with a cane. Appointments made for future dates, sent home. 1/4/2017 wife drove me to another Hospital. Emergency room did spinal tap, results showed GBS, checked into hospital and treated for GBS with IVIG, five daily treatments of IVIG.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Walking aid user
Clinical narrative: 12/31/2016 initial tingling in feet. 1/1/2017 unable to walk steady, used a cane, went to emergency room at hospital. Sent home. 1/4/2017 saw Dr. at Clinic, walking with a cane. Appointments made for future dates, sent home. 1/4/2017 wife drove me to another Hospital. Emergency room did spinal tap, results showed GBS, checked into hospital and treated for GBS with IVIG, five daily treatments of IVIG.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Headache, Myalgia, Pain
Clinical narrative: Patient is complaining that she is having headache, dizziness, muscle pain, and pain all over her body; arm is hurting and she had upset stomach; all this problems occurred in the morning, after she received the shots the night before.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient is complaining that she is having headache, dizziness, muscle pain, and pain all over her body; arm is hurting and she had upset stomach; all this problems occurred in the morning, after she received the shots the night before.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Neck pain
Clinical narrative: Entire body aches, headache, dizziness, nausea, pain in left arm from below elbow up into the neck. Lasted 10 - 14 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Entire body aches, headache, dizziness, nausea, pain in left arm from below elbow up into the neck. Lasted 10 - 14 days.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal discomfort, Palpitations
Clinical narrative: Patient described feeling her heart racing, palpitations, and gastrointestinal upset that lasted from approximately 11pm 8/27/18  to 7am 8/28/18.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope, Vaccination site haemorrhage
Clinical narrative: Patient exhibited syncope after vaccination as administered. Patient stated that she felt dizzy and nauseous after looking over her shoulder and realizing that she had a slight bleed at the area where the vaccination was administered. She then lost consciousness for about three minutes and still felt nauseous after regaining consciousness. She was eventually able to respond to her name and was supported by the pharmacy staff until the paramedics arrived on the scene.
Age: 60.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Vaccines were given on August 24. Patient called pharmacy on August 27 to report her left arm was still in pain and impacting her normal function. On August 28, patient reported her right arm was still in pain but her left arm was ok.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Skin burning sensation
Clinical narrative: Patient received SHINGRIX vaccine at a local pharmacy. 2 days later he developed burning and itching on his right torso. He was seen at urgent care and diagnosed with shingles. He was given a prescription for Valcyclovir but several days later broke out in a rash.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Abdominal pain, Diarrhoea, Formication, Injection site erythema, Injection site induration
Clinical narrative: Pt reports experiencing symptoms about 30 minutes after injections: abdominal cramps, nausea, excess sputum production but no dyspnea, anxiety, desperation, and stress. She reports loose stools towards the end of the night. She also report nausea for the last few days. She also reports pruritis over scalp "I feel like I have ants and spiders crawling over my body:" She reports induration, redness and tenderness over left deltoid- she states " it feels like I got hit on the arm, a sting to my arm".
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Nausea, Pruritus, Sputum increased
Clinical narrative: Pt reports experiencing symptoms about 30 minutes after injections: abdominal cramps, nausea, excess sputum production but no dyspnea, anxiety, desperation, and stress. She reports loose stools towards the end of the night. She also report nausea for the last few days. She also reports pruritis over scalp "I feel like I have ants and spiders crawling over my body:" She reports induration, redness and tenderness over left deltoid- she states " it feels like I got hit on the arm, a sting to my arm".
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Mobility decreased, Muscular weakness, Vision blurred
Clinical narrative: Patient purports experiencing overwhelming muscle weakness so much so she could not sit up in bed. She slid off the side of her bed yet could not move and lay on the floor for 2.5 hours before she could maneuver to her bathroom. She experienced severe muscle weakness and dizziness and blurred vision for several days and says she did not feel normalcy until 8/25/18.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Patient contacted pharmacy around 5:30PM 8/27/18 and said her lips were swollen. I advised patient to call on call PCP Dr and to take BENADRYL 25mg. I also asked her to not be alone and call back in 1 hour and 2 hours. After the 1 hour phone call her swelling was reduced. Patient also has EPIPEN on hand for other allergies. After 2 hour call much better, checked in with patient 8/28/18 morning and swelling was gone. Asked her to follow up with her PCP and Dr.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site warmth, Ocular hyperaemia
Clinical narrative: The patient received her vaccination and was fine. She was home reading, drinking tea, and playing game and someone noticed that her eye was "blood red." This was approximately 90-minutes post-injection. She hadn't had any noticeable symptoms, and felt no differently. She looked in the mirror and noticed the red color, and after a bit she did notice a slight bit of itching.  The patient's injection site is reported as normal with just a bit of warmness but no redness at the moment. The injection site does not hurt, and she reports no rash, redness, or swelling anywhere else on her arm(s), face, and/or body. She reports no other symptoms other than the eye redness and slight itching.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: Pain at injection site and not feeling well.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Fever of 100° for 33 hours. Chills off and on for 33 hours. Sore arm for 60 hours. Fatigue for 33 hours. Aching joints and muscles for 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 100° for 33 hours. Chills off and on for 33 hours. Sore arm for 60 hours. Fatigue for 33 hours. Aching joints and muscles for 24 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever a couple of hours after vaccinations. Redness around injection site right thigh. Next day, right thigh swollen, hot and red. Thigh continued to swell over next couple of days. Redness and swelling eventually went down approximately 7 days later.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Rash, Rash erythematous
Clinical narrative: Patient stated awoke in the morning with red rash all over face. Also stated injection site pain and fatigue. However, patient stated has a history of fatigue and did not believe this to be related to the vaccination. The patient was advised to monitor and consider contacting her doctor. The doctor was contacted and they stated they will contact her to have her come in for follow up.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site, Cephalexin prescribed and patient responding to treatment.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: She came to report a very intense bruise that is painful on her arm. It started after she got the injection on 8/26/18.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient had Shingles outbreak a day or so after the vaccination. Treated with VALTREX for 3 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to pharmacy on 8/28/18, stated that her injection site was swollen and painful for 5 days, it was a "knot". She said she had red streaks several inches wide and 3 inches long that started on second day through the 5th day. She said it had resolved when I asked her to show me her arm, with today being the fifth day. It therefore couldn't have lasted 5 days. This was her second SHINGRIX vaccine to complete the series, the first being given by me on 3/22/18 at 11 am and she never reacted. Also, her husband got his first SHINGRIX vaccine by me on 8/23/18 right after her and he did not have an adverse reaction.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site haemorrhage, Syncope
Clinical narrative: Patient felt lightheaded and fainted while exiting the store. Patient did have bleeding at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red and swollen and warm touch.
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Fever of 100.9 to 101.1 since 6:30 pm on 08/28/18.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient's left arm started hurting shortly after getting her flu vaccine, then she developed a warm, red rash on left arm. Patient took TYLENOL and the next day (8/28) her pain was better, but the rash was still present. Patient came into pharmacy to report the event. Right arm (pneumo vaccine arm) had no issues. Pharmacist consulted patient on supportive care (using hydrocortisone/BENADRYL for rash), continuing TYLENOL for soreness/pain. Also, what to watch out for, spreading rash, fever, hardness to call doctor/go to urgent care/ER immediately. Also, consulted pt on calling Dr to get assessed if they felt the need to be.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events. No treatment needed. Incorrect vaccine given.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Shortly after vaccination [a few hours], patient stated she had severe pain in her right arm as well as some loss of mobility. She attempted contacting her PCP's office but they were closed. She contacted the pharmacy and stated she had already tried OTC TYLENOL and topical ice packs but they did not help. She was advised to see a physician either at an urgent care clinic or ER if the pain was unbearable. Upon follow up the next day, patient said she was given some form of oxycodone in the hospital the previous night for pan and it helped. She also received a prescription for Ibuprofen 600mg. According to patient, at the time of follow up, her pain has been decreasing and mobility slowly returning.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Crying, Fear, Feeling abnormal, Injection site pain, Loss of consciousness
Clinical narrative: Suddenly after administering last vaccine MMR around 11:10 AM child experienced a general body rigidity and eyes were noted open but fixed. Was not responsive during this time, suddenly recovered at (sec. later) crying saying "she was scared". Ice packs were placed on neck area. Laid her down on floor with feet elevated. Sent to be evaluated by Hospital. Immediately, after placing last vaccine (MMR) pt. said "it hurts" then child experienced a general body rigidity and her eyes were noted to open but fixed, she was not responsive during this time, this reaction lasted about 10 seconds, as she suddenly recovered, she started crying, stated "she was very scared" mom holding in her arms during this time, then we laid her down on a matt on the floor and elevated her feet. Her B/P was 90/80 and pt. appeared pale. Pt. described experiencing a moment of total black out. Ice packs were positioned on neck area and forehead. Also juice given which she tolerated well. She started regaining pink color on her face and at this time she was verbalizing she was feeling much better. This all was about 10 minutes after reaction. B/P was retaken 100/80. We retained the pt. of total of 30 minutes before letting her go. Pt. was reported "not feeling quite herself and felt nauseous and denied any other symptoms. Due to her complaints, mother to take her to hospital ER for evaluation. We offered to call 911, but mother declined and chose to drive her herself. Pt. left with holding mom's arm and with good spirits, smiling, no problems noted ambulating.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Muscle rigidity, Nausea, Pallor, Staring, Unresponsive to stimuli
Clinical narrative: Suddenly after administering last vaccine MMR around 11:10 AM child experienced a general body rigidity and eyes were noted open but fixed. Was not responsive during this time, suddenly recovered at (sec. later) crying saying "she was scared". Ice packs were placed on neck area. Laid her down on floor with feet elevated. Sent to be evaluated by Hospital. Immediately, after placing last vaccine (MMR) pt. said "it hurts" then child experienced a general body rigidity and her eyes were noted to open but fixed, she was not responsive during this time, this reaction lasted about 10 seconds, as she suddenly recovered, she started crying, stated "she was very scared" mom holding in her arms during this time, then we laid her down on a matt on the floor and elevated her feet. Her B/P was 90/80 and pt. appeared pale. Pt. described experiencing a moment of total black out. Ice packs were positioned on neck area and forehead. Also juice given which she tolerated well. She started regaining pink color on her face and at this time she was verbalizing she was feeling much better. This all was about 10 minutes after reaction. B/P was retaken 100/80. We retained the pt. of total of 30 minutes before letting her go. Pt. was reported "not feeling quite herself and felt nauseous and denied any other symptoms. Due to her complaints, mother to take her to hospital ER for evaluation. We offered to call 911, but mother declined and chose to drive her herself. Pt. left with holding mom's arm and with good spirits, smiling, no problems noted ambulating.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Cognitive disorder, Full blood count, Human chorionic gonadotropin, Hypertonia, Hypotension
Clinical narrative: Suddenly after administering last vaccine MMR around 11:10 AM child experienced a general body rigidity and eyes were noted open but fixed. Was not responsive during this time, suddenly recovered at (sec. later) crying saying "she was scared". Ice packs were placed on neck area. Laid her down on floor with feet elevated. Sent to be evaluated by Hospital. Immediately, after placing last vaccine (MMR) pt. said "it hurts" then child experienced a general body rigidity and her eyes were noted to open but fixed, she was not responsive during this time, this reaction lasted about 10 seconds, as she suddenly recovered, she started crying, stated "she was very scared" mom holding in her arms during this time, then we laid her down on a matt on the floor and elevated her feet. Her B/P was 90/80 and pt. appeared pale. Pt. described experiencing a moment of total black out. Ice packs were positioned on neck area and forehead. Also juice given which she tolerated well. She started regaining pink color on her face and at this time she was verbalizing she was feeling much better. This all was about 10 minutes after reaction. B/P was retaken 100/80. We retained the pt. of total of 30 minutes before letting her go. Pt. was reported "not feeling quite herself and felt nauseous and denied any other symptoms. Due to her complaints, mother to take her to hospital ER for evaluation. We offered to call 911, but mother declined and chose to drive her herself. Pt. left with holding mom's arm and with good spirits, smiling, no problems noted ambulating.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, HEP, IPV, MMR, TDAP
Symptoms: Liver function test, Loss of consciousness, Metabolic function test, Muscle rigidity, Urticaria
Clinical narrative: Suddenly after administering last vaccine MMR around 11:10 AM child experienced a general body rigidity and eyes were noted open but fixed. Was not responsive during this time, suddenly recovered at (sec. later) crying saying "she was scared". Ice packs were placed on neck area. Laid her down on floor with feet elevated. Sent to be evaluated by Hospital. Immediately, after placing last vaccine (MMR) pt. said "it hurts" then child experienced a general body rigidity and her eyes were noted to open but fixed, she was not responsive during this time, this reaction lasted about 10 seconds, as she suddenly recovered, she started crying, stated "she was very scared" mom holding in her arms during this time, then we laid her down on a matt on the floor and elevated her feet. Her B/P was 90/80 and pt. appeared pale. Pt. described experiencing a moment of total black out. Ice packs were positioned on neck area and forehead. Also juice given which she tolerated well. She started regaining pink color on her face and at this time she was verbalizing she was feeling much better. This all was about 10 minutes after reaction. B/P was retaken 100/80. We retained the pt. of total of 30 minutes before letting her go. Pt. was reported "not feeling quite herself and felt nauseous and denied any other symptoms. Due to her complaints, mother to take her to hospital ER for evaluation. We offered to call 911, but mother declined and chose to drive her herself. Pt. left with holding mom's arm and with good spirits, smiling, no problems noted ambulating.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Eye swelling, Throat irritation
Clinical narrative: The mother specifies that the eyes got swollen and the throat was bothering him.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Facial neuralgia, Headache, Muscle spasms, Noninfective gingivitis
Clinical narrative: Fever, chills, muscle spasms, headache x 9 days. Lesions, cold sores on gums x 2-3 weeks. Facial neuralgia (unknown course).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin lesion
Clinical narrative: Fever, chills, muscle spasms, headache x 9 days. Lesions, cold sores on gums x 2-3 weeks. Facial neuralgia (unknown course).
Age: 59.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Feeling abnormal, Mass, Pain
Clinical narrative: Patient has lump which is painful and also not feeling very good after taking vaccine.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: One day after varicella vaccine at injection site (L) upper arm 5cm area of induration with redness, warmth and tender to touch. Treatment BACTRIM DS BIDx7-10d. Started BACTRIM 8/21/18.
Age: 55.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, warmth, redness, itching at injection site. RN recommended "ice, Benadryl cream-call back if no improvement or worse hives, neck and facial swelling occur or temp greater than 101 degrees F.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Headache, Lethargy, Malaise
Clinical narrative: 102.2 degrees fever, chills, aches, lethargy, headache, sore throat, felt sick for about 21.2 day, took ADVIL, bedrest.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 102.2 degrees fever, chills, aches, lethargy, headache, sore throat, felt sick for about 21.2 day, took ADVIL, bedrest.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Rash erythematous, Tenderness
Clinical narrative: Patient stated the shot was given on the side of her bicep muscle which caused her arm to swell, soreness and a red rash which was tender to touch. She applied ice and took TYLENOL OTC.
Age: 26.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Area where shots given is very painful and had a 3 inch radius of redness, and arm felt hard.
Age: 18.0
Sex: F
Vaccine: IPV, MMR, MNQ, VARCEL
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: Headache and weakness within 24 hrs. Fever within 72 hrs. Continued headache, fever spiking to 104.1 for over a week.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Headache, Night sweats, Pyrexia
Clinical narrative: Mom reports the evening after vaccination he woke up with severe headache and fever. Also c/o night sweats. Afebrile the following day. H/A resolved spontaneously. Mom related reaction to me at sibs well exam on 8/27/18.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted a few minutes after receiving immunizations in our clinic.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Blood calcium increased, Blood creatinine increased, Blood glucose normal, Electrocardiogram normal, Fall
Clinical narrative: The day of Sunday 8/19/18, Patient felt very tired. After dinner he wen to play video games (as he often does). His sister checked on him about 8:30pm and found him slumped over his computer, unresponsive. 911 called. No abnl movements or sounds heard. Had bit tongue on (R) but no incontinence. Took 30+ min to "come-to". Also found to have an impaction Fx of his (R) Prox humerus - Hill sachs" deformity may need surgery on shoulder.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Full blood count normal, Humerus fracture, Nuclear magnetic resonance imaging brain normal, Tongue biting
Clinical narrative: The day of Sunday 8/19/18, Patient felt very tired. After dinner he wen to play video games (as he often does). His sister checked on him about 8:30pm and found him slumped over his computer, unresponsive. 911 called. No abnl movements or sounds heard. Had bit tongue on (R) but no incontinence. Took 30+ min to "come-to". Also found to have an impaction Fx of his (R) Prox humerus - Hill sachs" deformity may need surgery on shoulder.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Ultrasound scan normal, Unresponsive to stimuli
Clinical narrative: The day of Sunday 8/19/18, Patient felt very tired. After dinner he wen to play video games (as he often does). His sister checked on him about 8:30pm and found him slumped over his computer, unresponsive. 911 called. No abnl movements or sounds heard. Had bit tongue on (R) but no incontinence. Took 30+ min to "come-to". Also found to have an impaction Fx of his (R) Prox humerus - Hill sachs" deformity may need surgery on shoulder.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Headache, Nausea, Pain
Clinical narrative: Chills, headache, body aches, nausea. Symptoms continued to get worse for 2 days. Went to ER where I was given IV fluids and anti-nausea meds. Feel much better following treatment.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dyspnoea, Electrocardiogram normal, Wheezing
Clinical narrative: Reported labored breathing and wheezing. EKG normal, history of SVT at birth.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Pt. C/O dizziness/lightheadedness/neck feeling weird.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: Macular rash to chest and L arm night after receiving vaccine rash resolved next day, residual soreness-soft swelling L arm.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia
Clinical narrative: Fever of 101.4.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: About 5 minutes after GARDASIL was given patient started feeling dizzy and pale looking. She was out in supine position and vital signs were taken W/C showed WNL. She recovered after 10 minutes and went home.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Myalgia, Pain, Paraesthesia, Rash pustular
Clinical narrative: This case was reported by a nurse and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and influenza-like symptoms. On an unknown date, the outcome of the vaccination failure, shingles and influenza-like symptoms were unknown. The reporter considered the vaccination failure and shingles to be related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter had mentioned that they had a patient who had flu like symptoms and also a mild case of shingles after receiving SHINGRIX. The patient felt that the shingle was caused by the SHINGRIX. This case was considered as suspected vaccination failure as, precise time to onset, details regarding immunization schedule and laboratory confirmation was not reported in the case. The reporter agreed to be contacted for follow up. This case has been linked with case US2018GSK152331, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Vaccination failure
Clinical narrative: This case was reported by a nurse and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and influenza-like symptoms. On an unknown date, the outcome of the vaccination failure, shingles and influenza-like symptoms were unknown. The reporter considered the vaccination failure and shingles to be related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter had mentioned that they had a patient who had flu like symptoms and also a mild case of shingles after receiving SHINGRIX. The patient felt that the shingle was caused by the SHINGRIX. This case was considered as suspected vaccination failure as, precise time to onset, details regarding immunization schedule and laboratory confirmation was not reported in the case. The reporter agreed to be contacted for follow up. This case has been linked with case US2018GSK152331, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported adverse event on 08/29/2018. She got the vaccination on 04/09/2018 at 2pm. She states that the reaction happened about 2 to 3 hours after the shot. Symptoms were redness and swelling of the entire injected upper arm and pain. The symptoms persisted for about a month, with symptoms starting to subside after 3 weeks.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported adverse event on 08/29/2018. She got the vaccination on 04/09/2018 at 2pm. She states that the reaction happened about 2 to 3 hours after the shot. Symptoms were redness and swelling of the entire injected upper arm and pain. The symptoms persisted for about a month, with symptoms starting to subside after 3 weeks.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Exposure during pregnancy, Pericarditis
Clinical narrative: Pericarditis temporally associated with SPV received 9 days earlier.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Cardiovascular evaluation, Laboratory test, Pericarditis, Vaccination complication
Clinical narrative: Pericarditis temporally associated with SPV received 9 days earlier.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stroke in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On 14th August 2018, 21 days after receiving SHINGRIX, the patient experienced fall and dizziness. In August 2018, the patient experienced stroke (serious criteria GSK medically significant) and shingles. On 15th August 2018, the patient experienced walking difficulty. On an unknown date, the patient experienced rash. The patient was treated with VALTREX. On an unknown date, the outcome of the stroke was unknown and the outcome of the shingles, walking difficulty, fall, rash and dizziness were not recovered/not resolved. It was unknown if the reporter considered the stroke, shingles, walking difficulty, fall, rash and dizziness to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, two weeks after SHINGRIX shot experienced shingles for the first time. The patient still had a rash on back at the time of reporting. The physician prescribed VALTREX, three doses a day to the patient. On 14th August 2018, the patient felt dizzy and she kept falling to left. The patient reported that, she almost had a stroke. On the day of reporting, in the morning, the patient's physician saw the patient and did a test. The patient could not walk straight. The physician ordered nuclear magnetic resonance imaging (MRI). The patient requested refund from Shingles shot. The patient had provided receipt, which was received from pharmacy.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Dizziness, Fall, Gait disturbance, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stroke in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On 14th August 2018, 21 days after receiving SHINGRIX, the patient experienced fall and dizziness. In August 2018, the patient experienced stroke (serious criteria GSK medically significant) and shingles. On 15th August 2018, the patient experienced walking difficulty. On an unknown date, the patient experienced rash. The patient was treated with VALTREX. On an unknown date, the outcome of the stroke was unknown and the outcome of the shingles, walking difficulty, fall, rash and dizziness were not recovered/not resolved. It was unknown if the reporter considered the stroke, shingles, walking difficulty, fall, rash and dizziness to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, two weeks after SHINGRIX shot experienced shingles for the first time. The patient still had a rash on back at the time of reporting. The physician prescribed VALTREX, three doses a day to the patient. On 14th August 2018, the patient felt dizzy and she kept falling to left. The patient reported that, she almost had a stroke. On the day of reporting, in the morning, the patient's physician saw the patient and did a test. The patient could not walk straight. The physician ordered nuclear magnetic resonance imaging (MRI). The patient requested refund from Shingles shot. The patient had provided receipt, which was received from pharmacy.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stroke in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On 14th August 2018, 21 days after receiving SHINGRIX, the patient experienced fall and dizziness. In August 2018, the patient experienced stroke (serious criteria GSK medically significant) and shingles. On 15th August 2018, the patient experienced walking difficulty. On an unknown date, the patient experienced rash. The patient was treated with VALTREX. On an unknown date, the outcome of the stroke was unknown and the outcome of the shingles, walking difficulty, fall, rash and dizziness were not recovered/not resolved. It was unknown if the reporter considered the stroke, shingles, walking difficulty, fall, rash and dizziness to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, two weeks after SHINGRIX shot experienced shingles for the first time. The patient still had a rash on back at the time of reporting. The physician prescribed VALTREX, three doses a day to the patient. On 14th August 2018, the patient felt dizzy and she kept falling to left. The patient reported that, she almost had a stroke. On the day of reporting, in the morning, the patient's physician saw the patient and did a test. The patient could not walk straight. The physician ordered nuclear magnetic resonance imaging (MRI). The patient requested refund from Shingles shot. The patient had provided receipt, which was received from pharmacy.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: I awakened with tingling in fingers, hands, feet, toes, up to mid calf. My lower legs, ankles and feet do not work. My mobility has decreased overnight from speed walking to wobbly with great fear of falling. I struggle to rise from chair or walk smoothly.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fear of falling, Gait disturbance, Mobility decreased, Musculoskeletal disorder, Paraesthesia
Clinical narrative: I awakened with tingling in fingers, hands, feet, toes, up to mid calf. My lower legs, ankles and feet do not work. My mobility has decreased overnight from speed walking to wobbly with great fear of falling. I struggle to rise from chair or walk smoothly.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site extravasation, Ophthalmic herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of ophthalmic herpes zoster in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th March 2018, the patient received the 1st dose of SHINGRIX. On 24th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, not applicable after receiving SHINGRIX and 14 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye swelling and vaccine underdose. The patient was treated with VALTREX. On an unknown date, the outcome of the ophthalmic herpes zoster, eye swelling and vaccine underdose were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. While receiving 1st dose large amount of fluid came out of injection, which led to underdose. Two and half weeks after 2nd dose, the patient was returned to the pharmacist for her last dose of pneumonia shot. The pharmacist noticed that the patient eye was puffy and advised to consult physician. Two and half weeks after 2nd dose the patient was diagnosed with eye shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Injection site extravasation, Ophthalmic herpes zoster, Underdose
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of ophthalmic herpes zoster in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th March 2018, the patient received the 1st dose of SHINGRIX. On 24th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, not applicable after receiving SHINGRIX and 14 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye swelling and vaccine underdose. The patient was treated with VALTREX. On an unknown date, the outcome of the ophthalmic herpes zoster, eye swelling and vaccine underdose were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. While receiving 1st dose large amount of fluid came out of injection, which led to underdose. Two and half weeks after 2nd dose, the patient was returned to the pharmacist for her last dose of pneumonia shot. The pharmacist noticed that the patient eye was puffy and advised to consult physician. Two and half weeks after 2nd dose the patient was diagnosed with eye shingles.