chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient reported fever, chills, diarrhea, and a sore arm after receiving vaccinations. On Saturday 10/20 patient reported to pharmacy. He stated the fever, chills, and diarrhea had subsided. Pt had diffuse, red, swollen area on his right bicep. On 10/21 patient reported that redness/swelling had started to go down. On 10/22 patient reported redness/swelling had improved, but a quarter-sized "knot" had formed on his right bicep that he first observed on 10/20 or 10/21. On 10/23 patient reported all symptoms had resolved except for the quarter-sized knot on his right bicep. He presented to the pharmacy on 10/23. A red, quarter-sized bump was observed between the right deltoid and right bicep. Per the immunizing pharmacist, location did not appear to be at the exact injection site. He denied ever having a reaction like this before. Over the next several days, patient reported bump remained the same size and color (red). By 10/29 the bump remained the same. The patient plans to request an appointment with his doctor's office if bump does not resolve by 10/31 or 11/1. Patient reported he called his doctor regarding the bump on 10/25 and 10/26 and the doctor's office told him to monitor the bump and request an appointment if it does not improve.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient reported fever, chills, diarrhea, and a sore arm after receiving vaccinations. On Saturday 10/20 patient reported to pharmacy. He stated the fever, chills, and diarrhea had subsided. Pt had diffuse, red, swollen area on his right bicep. On 10/21 patient reported that redness/swelling had started to go down. On 10/22 patient reported redness/swelling had improved, but a quarter-sized "knot" had formed on his right bicep that he first observed on 10/20 or 10/21. On 10/23 patient reported all symptoms had resolved except for the quarter-sized knot on his right bicep. He presented to the pharmacy on 10/23. A red, quarter-sized bump was observed between the right deltoid and right bicep. Per the immunizing pharmacist, location did not appear to be at the exact injection site. He denied ever having a reaction like this before. Over the next several days, patient reported bump remained the same size and color (red). By 10/29 the bump remained the same. The patient plans to request an appointment with his doctor's office if bump does not resolve by 10/31 or 11/1. Patient reported he called his doctor regarding the bump on 10/25 and 10/26 and the doctor's office told him to monitor the bump and request an appointment if it does not improve.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: DIARRHEA, STOMACH PAINS, SLEEPY FEELING, HEADACHE, FEELING TIRED AND WEAK, CHILLS AND NOT HUNGRY.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Somnolence
Clinical narrative: DIARRHEA, STOMACH PAINS, SLEEPY FEELING, HEADACHE, FEELING TIRED AND WEAK, CHILLS AND NOT HUNGRY.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient complained that it was given too high and her arm is continuing to hurt even now. She is going to make a doctor appointment.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: Patient got a rash, which was reported to our pharmacy by the physician's nurse. Nothing was prescribed for him; they just called to let us know.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood magnesium, Blood thyroid stimulating hormone, Culture urine, Full blood count, Metabolic function test
Clinical narrative: Seizure (Grand Mal?); Emergency Dept. visit. Referred to family physician and /or Neurologist.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure, Toxicologic test, Urine analysis
Clinical narrative: Seizure (Grand Mal?); Emergency Dept. visit. Referred to family physician and /or Neurologist.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient claims she was fine during the time of administration. States that it wasn't until later on at night where the injection site became red, swollen and itching. As time went on, the injection site became even more swollen and started moving down her arm. At this time the patient was concerned and went to the ER. Vaccine was administered around 4pm and patient went to the ER after 9 pm. Adverse reactions did not start till a few hours after the injection, per the patient.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain
Clinical narrative: Very sore at the injection site for 25 days since being injected.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient called approx. 7 hours after vaccine administered complaining of itching, but no hives and feeling like her throat was closing, "but it's not"; instructed patient to go to ER if she felt like she couldn't breathe.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Injected limb mobility decreased, Micturition urgency, Pain
Clinical narrative: I received a second pneumonia vaccine shot on 10/25/2018. A year ago, I received PREVNAR 13 and had no side effects other than a sore arm. When I received PNEUMOVAX 23, within 9 hours, I could barely use my left arm. Within 11 hours, I had terrible chills and ached all over my body, including the arm from shoulder to wrist. Went to bed, had strong need to urinate in about 2 1/2 hours. That seem to relieve symptoms a bit so I drank water whenever I woke for rest of the night. Symptoms improved each time I urinated. I was less weak by morning and chills were gone.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: I received a second pneumonia vaccine shot on 10/25/2018. A year ago, I received PREVNAR 13 and had no side effects other than a sore arm. When I received PNEUMOVAX 23, within 9 hours, I could barely use my left arm. Within 11 hours, I had terrible chills and ached all over my body, including the arm from shoulder to wrist. Went to bed, had strong need to urinate in about 2 1/2 hours. That seem to relieve symptoms a bit so I drank water whenever I woke for rest of the night. Symptoms improved each time I urinated. I was less weak by morning and chills were gone.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Endotracheal intubation
Clinical narrative: Patient with PMH asthma, h/o asthma exacerbation requiring intubation and also on immunotherapy (NUCALA), which pt reportedly received today. Pt received influenza vaccine today and developed SOB approximately 10 minutes later, self-administered EPIPEN and inhaler with no symptom relief. Pt was brought to ED where emergent pharmacologic therapy (diphenhydramine, famotidine, steroids, DUONEB, magnesium sulfate) was provided but did not relieve symptoms. Pt was intubated.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Constipation, Diarrhoea, Hypersomnia, Injection site pain
Clinical narrative: On 10/23/18, at approximately 12 noon, I received the 2nd dose of the SHINGRIX vaccine from my medical provider. (I previously had the first dose in April 2018 with no problems or symptoms). I felt fine the rest of the day. The very next day I had severe diarrhea, slight nausea, and lots of stomach churning. I spent the day in bed and took 4 IMODIUM doses. I drank lots of water and ate toast, rice, crackers and cheese. I slept a lot. I was ok the next day (10/24/18), and back to normal by 10/25/18. I had no bowel movements at all until 10/26/18, which were slightly constipated. I have also had a very sore left shoulder with slight swelling at the site of the vaccine injection since I received it on 10/23/18. It prevents me from sleeping on my left side at night. I am reporting these symptoms after talking to other women who had a similar experience with this vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea
Clinical narrative: On 10/23/18, at approximately 12 noon, I received the 2nd dose of the SHINGRIX vaccine from my medical provider. (I previously had the first dose in April 2018 with no problems or symptoms). I felt fine the rest of the day. The very next day I had severe diarrhea, slight nausea, and lots of stomach churning. I spent the day in bed and took 4 IMODIUM doses. I drank lots of water and ate toast, rice, crackers and cheese. I slept a lot. I was ok the next day (10/24/18), and back to normal by 10/25/18. I had no bowel movements at all until 10/26/18, which were slightly constipated. I have also had a very sore left shoulder with slight swelling at the site of the vaccine injection since I received it on 10/23/18. It prevents me from sleeping on my left side at night. I am reporting these symptoms after talking to other women who had a similar experience with this vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Muscle spasms, Vomiting
Clinical narrative: I received the 2nd SHINGRIX shot. 30 hours later I became ill: Cramps, diarrhea, vomiting and shivering.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Aphasia, Fatigue, Fear, Migraine, Sinus pain
Clinical narrative: Had Senior FLUAD vaccine. Two hours later was exhausted. Two hours later had migraine headache, painful sinus, vaccine site was very painful. Then I had aphasia. I was trying to talk with my husband and all my words came out wrong - substituted wrong consonants at beginning of words, used wrong vocabulary, was just not understandable. I was quite scared, and my husband volunteered to take me to the ER. I didn't want to go because I knew it would be an extremely long work up. Feel better today, but still very tired.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Speech disorder, Vaccination site pain
Clinical narrative: Had Senior FLUAD vaccine. Two hours later was exhausted. Two hours later had migraine headache, painful sinus, vaccine site was very painful. Then I had aphasia. I was trying to talk with my husband and all my words came out wrong - substituted wrong consonants at beginning of words, used wrong vocabulary, was just not understandable. I was quite scared, and my husband volunteered to take me to the ER. I didn't want to go because I knew it would be an extremely long work up. Feel better today, but still very tired.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Ear pain, Eye pruritus, Headache, Malaise
Clinical narrative: I received the flu shot and 3 hours after became severely ill. My eye were itching facial and throat swelling. Chills, severe headache,ear ache and massive headache. I almost went emergency room but took BENADRYL and cold cloths to help thru the night. I have the flu shot for 18years never had such a severe reaction.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Swelling face, Vaccination complication
Clinical narrative: I received the flu shot and 3 hours after became severely ill. My eye were itching facial and throat swelling. Chills, severe headache,ear ache and massive headache. I almost went emergency room but took BENADRYL and cold cloths to help thru the night. I have the flu shot for 18years never had such a severe reaction.
Age: 50.0
Sex: U
Vaccine: TYP
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Influenza like illness, Joint stiffness
Clinical narrative: Hello, I am an adult in good health. Before my vacation traveling started, I was advised to take the typhoid vaccine. My doctor prescribed the VIVOTIF EC Cap (one pill every other day four times in total). After initiating the first capsule, I developed abdominal pain followed by diarrhea. I finished the treatment as prescribed. However the following week, I experienced terrible aching, swollen and stiff pain in my hand joints which I had never experienced before. I reported this to my doctor and she wanted to wait and see. By 16Sep2018 before my vacation began, the aching had spread all over my body joints given me the feeling of having a flu but it was not a flu. I contacted my doctor again because walking was very painful and by this time I stopped going to the gym. I couldn't run or do weight lifting that I normally do. I was very perplexed because my diet and routines were not altered in any way. The only change was the administration of this vaccine the week prior before the onset of these symptoms. My doctor (Internist) suggested that I take ADVIL during my vacation to manage the ache/pain and stiffness. I took the ADVIL and then stopped since it didn't alleviate the pain/ache and the stiffness. It was very hard to do physical activities while I was on vacation. I had to move very slowly and it ached a lot when walking up and down the stairs or whenever joint movements were required, even putting clothes on/off. I still have this problem to this day. It has not subsided over time as I had hoped. I will make an appointment to see my doctor or referred specialist to perform some tests to determine the problem. I still have the package of this vaccine that I took.
Age: 50.0
Sex: U
Vaccine: TYP
Symptoms: Joint swelling, Loss of personal independence in daily activities, Pain
Clinical narrative: Hello, I am an adult in good health. Before my vacation traveling started, I was advised to take the typhoid vaccine. My doctor prescribed the VIVOTIF EC Cap (one pill every other day four times in total). After initiating the first capsule, I developed abdominal pain followed by diarrhea. I finished the treatment as prescribed. However the following week, I experienced terrible aching, swollen and stiff pain in my hand joints which I had never experienced before. I reported this to my doctor and she wanted to wait and see. By 16Sep2018 before my vacation began, the aching had spread all over my body joints given me the feeling of having a flu but it was not a flu. I contacted my doctor again because walking was very painful and by this time I stopped going to the gym. I couldn't run or do weight lifting that I normally do. I was very perplexed because my diet and routines were not altered in any way. The only change was the administration of this vaccine the week prior before the onset of these symptoms. My doctor (Internist) suggested that I take ADVIL during my vacation to manage the ache/pain and stiffness. I took the ADVIL and then stopped since it didn't alleviate the pain/ache and the stiffness. It was very hard to do physical activities while I was on vacation. I had to move very slowly and it ached a lot when walking up and down the stairs or whenever joint movements were required, even putting clothes on/off. I still have this problem to this day. It has not subsided over time as I had hoped. I will make an appointment to see my doctor or referred specialist to perform some tests to determine the problem. I still have the package of this vaccine that I took.
Sex: U
Vaccine: RV1
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Malaise, Peripheral coldness, Secretion discharge
Clinical narrative: Customer requested "high dose" flu vaccine from tech, entered 10:06pm. Tech confirmed with pt about any reactions to vaccines. Customer confirmed "never had any reaction to any vaccine and I double checked at time of shot, also stated only PCN true allergy, others listed really weren't and pt confirmed "never reacted to flu shot, had many times before. Discussed VIS, after vaccine, pt was told to hand around for 15 minutes after shot to make sure everything ok. Customer sat in chair talking on phone in Pharmacy waiting area. Shot was given approximately 10:30pm, at about 10:45 pm pt complained of "just not feeling well" felt like she had more "mucus" and cold hands, she thought she maybe was having a reaction to the flu shot, monitored pt, she was coherent and responsive, no other issues reported at that time. Customer also stated she usually takes care of her allergic reactions herself and she was going to take cimetidine, BENADRYL and her QVAR (2 puffs) (these are what she told EMT...I only saw her with inhaler in hand, never witnessed her use/take meds). Customer thought she may be hungry, she was given water and ate "2 snicker snack size" (made sure no allergies to these) and she also at a "lunchable" while Police Officer here. Pt limits calorie intake to 1000 calories per day. At approx. 10:58, pt requested 911 called, officer already on site at our location outside, he notified EMT who was on their way already. Fire dept showed up as well prior to EMT. Pt did discuss with Officer about 1000 calorie intake, thought maybe she was hungry. Pt also stated maybe she should take her "prednisone", we both advised against before EMT arrival and recommended pt shouldn't eat any more food. EMT's arrived, took over care. We (tech and Pharmacist) told ok to leave. Informed EMT's of FLUZONE-HD shot given and never reacted, possible meds pt took/used. Also noted food eaten and limited caloric intake of 1000 calories/day and PCN allergy. Pt confirmed PCN allergy, when they asked about any allergies. Pt walked out to ambulance next to EMT's responsive and alert at about 11:22pm. Followed up with ER report, pt was seen and observed by Dr., released at 2AM as OK. Pt was given DECADRON and eating when Dr. went into see her. Dr. reports said, pt may have had some reaction, but some anxiety as well.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysarthria, Hypoaesthesia
Clinical narrative: She was feeling numbness on her neck, both arms and had slurred speech.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Rash
Clinical narrative: Patient reported inability to lift arm for about 3 days after the vaccine. She reported using physical therapy herself to help with range of motion. She reports her arm is getting better than when it first occurred. Patient also reported a rash that developed 10-28-18 on the tops of her feet and legs. She reports one side is worse than the other.
Age: 50.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient states that there was extreme pain at site of injection and down entire arm at time of vaccination. Patient also states that a loud, long severe crunch was heard at time of injection. Pharmacist is unaware of any such claims. States pain has been ongoing since time of injection and doctors have advised to use antiinflammatories and heat.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Eye swelling, Headache, Ocular hyperaemia
Clinical narrative: Patient contacted us at pharmacy to inform us of the following reactions she had after receiving the vaccine: face, eyes were itching and swollen, coughing, sneezing, severe headache, eyes were red. She was able to breathe however throat was closing. Patient took 2 ADVIL and BENADRYL. She stated she was feeling better today but wasn't able to go to work.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Sneezing, Swelling face, Throat tightness
Clinical narrative: Patient contacted us at pharmacy to inform us of the following reactions she had after receiving the vaccine: face, eyes were itching and swollen, coughing, sneezing, severe headache, eyes were red. She was able to breathe however throat was closing. Patient took 2 ADVIL and BENADRYL. She stated she was feeling better today but wasn't able to go to work.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Per mom noticed Saturday morning (10/27) area red and swollen gradually gotten bigger now softball size. Warm to touch, and itchy. KEFLEX BID started for cellulitis. Sight marked for increasing severity.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm redness, swelling, warmth, and pain and itchiness; spreading over past two days, since receiving influenza vaccine to the same site.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Bruxism, Mastication disorder, Mouth swelling, Pain in jaw, Trismus
Clinical narrative: Locked jaw or clenched jaw, extremely painful lower jaw, hurt to talk or eat, was not able to chew; area under tongue was swollen for several days.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb injury, Mobility decreased, Pain
Clinical narrative: Patient developed SIRVA with symptoms of pain and a lack of mobility ongoing since 10/02/2018.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Feeling hot, Hypersensitivity, Peripheral swelling
Clinical narrative: Patient has swelling in arm, redness, and heat. She is also experiencing difficulty breathing. All are signs of an allergic reaction.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Pharyngeal oedema
Clinical narrative: Lips swelling and throat swelling on Oct 26th evening. Oct 27 in am, patient complained of lips still a little swollen but not throat. Patient took BENADRYL on Friday night and was going to repeat again Sat evening. Would notify pharmacy if symptoms persisted or got worse. Patient did not call again later on 10/26/18. Waited to fax until Mon Oct 29th to make sure patient did not call again. Have no more information from patient.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Retching, Vomiting
Clinical narrative: Vomit, diarrhea, dry heaving outcome, was given anti-vomit pill did not go back to school till Tues the following week.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Nausea, Pyrexia, Urticaria
Clinical narrative: Hives light headed weak, also low-grade fever and sick to stomach. Hives were off and on for last few days.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling, Vasodilatation
Clinical narrative: A few hours after flu shot, started getting numbness/paresthesia's and sharp/popping pain in (R) forearm. Since then, paresthesia remain, along with soreness at times of right forearm. Forearm, near wrist is slightly swollen and vein is distended at times, looks collapsed at times.
Age: 22.0
Sex: M
Vaccine: FLU4, HEPA, MENB
Symptoms: Seizure, Syncope
Clinical narrative: Pt. experienced syncope followed by seizure lasting approx. 30 sec. No hx of seizures.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV4, MENB, MNQ
Symptoms: Presyncope, Syncope
Clinical narrative: Near faint/syncope.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swollen by injection site.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has reported that on her Right arm where PNEUMOVAX 23 was administered, she has experienced swollen large area that was red with raised margins, and it was warm to touch. Patient had no fever. Patient took KEFLEX antibiotic that she had at home and symptoms were resolved over couple days.
Age: 1.17
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Tremor
Clinical narrative: Varicella, MMR, Flu vaccine given and pt developed increased T 104.0F overnight. Grandparents noted shaking and pt. being "out of sorts" for 30 seconds. Child was placed in tepid bath and put cool towels on her to bring temp down. Likely not a seizure. Fever continued until evening of 10/27/18.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling (R) thigh.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Device failure, Dizziness, Fall, Head injury
Clinical narrative: Patient received SHINGRIX vaccine on July 19, 2018, per a suggestion from the pharmacist. She was not advised of any side effects. The following morning around 4 AM she got up to go to the restroom. She fainted and fell off the toilet, hitting her head, cutting her lip and breaking her dentures. They were not repairable and had to be replaced at high cost. A visit to her PCP office confirmed a contusion of her left shoulder, face and lip, and broken dentures. She fainted a total of 3 times that day.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Complication associated with device, Contusion, Fall, Head injury, Injection site bruising
Clinical narrative: Patient received SHINGRIX vaccine on July 19, 2018, per a suggestion from the pharmacist. She was not advised of any side effects. The following morning around 4 AM she got up to go to the restroom. She fainted and fell off the toilet, hitting her head, cutting her lip and breaking her dentures. They were not repairable and had to be replaced at high cost. A visit to her PCP office confirmed a contusion of her left shoulder, face and lip, and broken dentures. She fainted a total of 3 times that day.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip injury, Oral contusion, Syncope
Clinical narrative: Patient received SHINGRIX vaccine on July 19, 2018, per a suggestion from the pharmacist. She was not advised of any side effects. The following morning around 4 AM she got up to go to the restroom. She fainted and fell off the toilet, hitting her head, cutting her lip and breaking her dentures. They were not repairable and had to be replaced at high cost. A visit to her PCP office confirmed a contusion of her left shoulder, face and lip, and broken dentures. She fainted a total of 3 times that day.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Hyperhidrosis, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stevens johnson syndrome in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 6th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 3 hrs after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria GSK medically significant), blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall. The patient was treated with allergy medication {nos} (Allergy Medication) and prednisone. In October 2018, the outcome of the stevens johnson syndrome, blister, fever, shortness of breath, injection site pain, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall were recovered/resolved. On an unknown date, the outcome of the sweating and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the stevens johnson syndrome, blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. After vaccination with the dose of SHINGRIX on the left arm, the patient experienced terrible side effects which included blistering lesions, possible Steven Johnson's syndrome. The patient stated that, her injection site was so sore that even the tough of the shirt would hurt her. The patient's eyes were swollen, she walked into a door and got a bump on her front head, that is goose egg bump. The patient's whole left side body was in pain from her neck, shoulder and leg. The patient also could not eat anything. The patient was not steady on her feet and she fell on her staircase of house.  The patient was exhausted and breaks down in sweat if she did anything around the house. The patient stated that about 3 hours after vaccination the events started and by the next day of the vaccination, the patient was in an absolute mess. The patient had visited her physician's office twice. The patient was taking Allergy medications and Prednisone 25 mg twice a day for a period of 3 days followed by 25 mg once a day for a period of three days. The physician contact details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stevens-Johnson syndrome, Tongue blistering
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stevens johnson syndrome in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 6th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 3 hrs after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria GSK medically significant), blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall. The patient was treated with allergy medication {nos} (Allergy Medication) and prednisone. In October 2018, the outcome of the stevens johnson syndrome, blister, fever, shortness of breath, injection site pain, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall were recovered/resolved. On an unknown date, the outcome of the sweating and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the stevens johnson syndrome, blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. After vaccination with the dose of SHINGRIX on the left arm, the patient experienced terrible side effects which included blistering lesions, possible Steven Johnson's syndrome. The patient stated that, her injection site was so sore that even the tough of the shirt would hurt her. The patient's eyes were swollen, she walked into a door and got a bump on her front head, that is goose egg bump. The patient's whole left side body was in pain from her neck, shoulder and leg. The patient also could not eat anything. The patient was not steady on her feet and she fell on her staircase of house.  The patient was exhausted and breaks down in sweat if she did anything around the house. The patient stated that about 3 hours after vaccination the events started and by the next day of the vaccination, the patient was in an absolute mess. The patient had visited her physician's office twice. The patient was taking Allergy medications and Prednisone 25 mg twice a day for a period of 3 days followed by 25 mg once a day for a period of three days. The physician contact details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Blister, Dyspnoea, Eye swelling, Fall
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stevens johnson syndrome in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 6th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 3 hrs after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria GSK medically significant), blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall. The patient was treated with allergy medication {nos} (Allergy Medication) and prednisone. In October 2018, the outcome of the stevens johnson syndrome, blister, fever, shortness of breath, injection site pain, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall were recovered/resolved. On an unknown date, the outcome of the sweating and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the stevens johnson syndrome, blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. After vaccination with the dose of SHINGRIX on the left arm, the patient experienced terrible side effects which included blistering lesions, possible Steven Johnson's syndrome. The patient stated that, her injection site was so sore that even the tough of the shirt would hurt her. The patient's eyes were swollen, she walked into a door and got a bump on her front head, that is goose egg bump. The patient's whole left side body was in pain from her neck, shoulder and leg. The patient also could not eat anything. The patient was not steady on her feet and she fell on her staircase of house.  The patient was exhausted and breaks down in sweat if she did anything around the house. The patient stated that about 3 hours after vaccination the events started and by the next day of the vaccination, the patient was in an absolute mess. The patient had visited her physician's office twice. The patient was taking Allergy medications and Prednisone 25 mg twice a day for a period of 3 days followed by 25 mg once a day for a period of three days. The physician contact details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeding disorder, Head injury, Hyperhidrosis, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stevens johnson syndrome in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 6th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 3 hrs after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria GSK medically significant), blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall. The patient was treated with allergy medication {nos} (Allergy Medication) and prednisone. In October 2018, the outcome of the stevens johnson syndrome, blister, fever, shortness of breath, injection site pain, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall were recovered/resolved. On an unknown date, the outcome of the sweating and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the stevens johnson syndrome, blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. After vaccination with the dose of SHINGRIX on the left arm, the patient experienced terrible side effects which included blistering lesions, possible Steven Johnson's syndrome. The patient stated that, her injection site was so sore that even the tough of the shirt would hurt her. The patient's eyes were swollen, she walked into a door and got a bump on her front head, that is goose egg bump. The patient's whole left side body was in pain from her neck, shoulder and leg. The patient also could not eat anything. The patient was not steady on her feet and she fell on her staircase of house.  The patient was exhausted and breaks down in sweat if she did anything around the house. The patient stated that about 3 hours after vaccination the events started and by the next day of the vaccination, the patient was in an absolute mess. The patient had visited her physician's office twice. The patient was taking Allergy medications and Prednisone 25 mg twice a day for a period of 3 days followed by 25 mg once a day for a period of three days. The physician contact details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stevens johnson syndrome in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 6th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 3 hrs after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria GSK medically significant), blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall. The patient was treated with allergy medication {nos} (Allergy Medication) and prednisone. In October 2018, the outcome of the stevens johnson syndrome, blister, fever, shortness of breath, injection site pain, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall were recovered/resolved. On an unknown date, the outcome of the sweating and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the stevens johnson syndrome, blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. After vaccination with the dose of SHINGRIX on the left arm, the patient experienced terrible side effects which included blistering lesions, possible Steven Johnson's syndrome. The patient stated that, her injection site was so sore that even the tough of the shirt would hurt her. The patient's eyes were swollen, she walked into a door and got a bump on her front head, that is goose egg bump. The patient's whole left side body was in pain from her neck, shoulder and leg. The patient also could not eat anything. The patient was not steady on her feet and she fell on her staircase of house.  The patient was exhausted and breaks down in sweat if she did anything around the house. The patient stated that about 3 hours after vaccination the events started and by the next day of the vaccination, the patient was in an absolute mess. The patient had visited her physician's office twice. The patient was taking Allergy medications and Prednisone 25 mg twice a day for a period of 3 days followed by 25 mg once a day for a period of three days. The physician contact details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stevens-Johnson syndrome, Swelling, Swollen tongue, Tenderness, Tongue blistering
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stevens johnson syndrome in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 6th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 3 hrs after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria GSK medically significant), blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall. The patient was treated with allergy medication {nos} (Allergy Medication) and prednisone. In October 2018, the outcome of the stevens johnson syndrome, blister, fever, shortness of breath, injection site pain, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall were recovered/resolved. On an unknown date, the outcome of the sweating and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the stevens johnson syndrome, blister, fever, sweating, shortness of breath, injection site pain, exhaustion, swollen tongue, tongue blistering, eye swelling, local swelling, general body pain, neck pain, shoulder pain, leg pain, unable to eat, unsteadiness and fall to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. After vaccination with the dose of SHINGRIX on the left arm, the patient experienced terrible side effects which included blistering lesions, possible Steven Johnson's syndrome. The patient stated that, her injection site was so sore that even the tough of the shirt would hurt her. The patient's eyes were swollen, she walked into a door and got a bump on her front head, that is goose egg bump. The patient's whole left side body was in pain from her neck, shoulder and leg. The patient also could not eat anything. The patient was not steady on her feet and she fell on her staircase of house.  The patient was exhausted and breaks down in sweat if she did anything around the house. The patient stated that about 3 hours after vaccination the events started and by the next day of the vaccination, the patient was in an absolute mess. The patient had visited her physician's office twice. The patient was taking Allergy medications and Prednisone 25 mg twice a day for a period of 3 days followed by 25 mg once a day for a period of three days. The physician contact details were provided.
Age: 49.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthralgia, Dizziness, Pyrexia
Clinical narrative: Fever dizzy and bad joint pains.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: I had severe pain that night. When the doctor injected me I felt that it was too high on the shoulder, much higher than any of the flu shots I had ever received. Luckily, my son who also received the same flu shot did not experience any discomfort. I have limited range of motion, now after 13 days, in my right arm. It pains me to raise my arm up and rotate it in front of me. It is the worst at night and when I wake up in the morning.
Age: 74.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: ERYTHEMA, INDURATION AT SITE.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Improper vaccine administered-Hep B desired by patient, Influenza was given.
Age: 74.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Feeling abnormal
Clinical narrative: Pt states that he just felt "like death" and will never get a flu shot again.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, itching, swelling at right deltoid area. Mother reports symptoms began approximately 20 minutes after vaccine was administered.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: Patient received his flu shot on 10/4/18 and about 2 hours later started with left deltoid pain. This was a bit more severe than typical pain he has experienced after receiving an immunization in the past. There was no redness or bruising. The pain has persisted since then and he called to be seen as it is now 3-1/2 weeks. There is mild pain at rest 2/10 and pain is worse with any right shoulder movement. He has difficulty cleaning in the shower, getting his shirt on and off and similar movements. At times he has felt severe sharp pains in the arm. No numbness or tingling. Otherwise he feels unremarkable. He denies any fever. He has not had any reactions to immunizations in the past right upper deltoid no visible deformity, no erythema or ecchymosis. Limited right shoulder ROM. Mild tenderness to deep palpation. ASSESSMENT AND PLAN: Adverse effect of vaccine, initial encounter; Acute pain of right shoulder; Limited range of motion (ROM) of shoulder. The location of the immunization administration appears to be correct. No evidence of cellulitis. Will have him try prednisone 20 mg twice daily ×2 days, 20 mg once daily ×2 days, 10 mg daily ×2 days. Recheck on Monday. Follow-up in about 6 days (around 11/5/2018) for recheck arm.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient received his flu shot on 10/4/18 and about 2 hours later started with left deltoid pain. This was a bit more severe than typical pain he has experienced after receiving an immunization in the past. There was no redness or bruising. The pain has persisted since then and he called to be seen as it is now 3-1/2 weeks. There is mild pain at rest 2/10 and pain is worse with any right shoulder movement. He has difficulty cleaning in the shower, getting his shirt on and off and similar movements. At times he has felt severe sharp pains in the arm. No numbness or tingling. Otherwise he feels unremarkable. He denies any fever. He has not had any reactions to immunizations in the past right upper deltoid no visible deformity, no erythema or ecchymosis. Limited right shoulder ROM. Mild tenderness to deep palpation. ASSESSMENT AND PLAN: Adverse effect of vaccine, initial encounter; Acute pain of right shoulder; Limited range of motion (ROM) of shoulder. The location of the immunization administration appears to be correct. No evidence of cellulitis. Will have him try prednisone 20 mg twice daily ×2 days, 20 mg once daily ×2 days, 10 mg daily ×2 days. Recheck on Monday. Follow-up in about 6 days (around 11/5/2018) for recheck arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Hepatic enzyme increased, Platelet count decreased
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of elevated liver enzymes in a 18-year-old female patient who received BEXSERO for prophylaxis. On 27th July 2018, the patient received the 1st dose of BEXSERO. On 1st September 2018, 36 days after receiving BEXSERO, the patient experienced fever. On 5th September 2018, the patient experienced elevated liver enzymes (serious criteria hospitalization). On an unknown date, the outcome of the elevated liver enzymes and fever were unknown. The reporter considered the elevated liver enzymes and fever to be related to BEXSERO. Additional information was received as follows: On 1st September 2018, the patient's body temperature was recorded as 103 degree F. On 3rd September 2018, the patient's white blood cells count was 1.4 and platelet count was down to 82. On 5th September 2018, the patient's liver enzymes were checked and they were Alanine aminotransferase 306, Aspartate aminotransferase 549 and Blood alkaline phosphatase 167. On 5th September 2018, the patient's white blood cells count was 2. On 3rd September 2018, the patient was hospitalized and transferred to another hospital on 5th September 2018. The patient was given further IV's. The reporter believed the only difference was that the patient had gotten her dose of BEXSERO. The reporter believed this was an adverse event related to the 1st dose of BEXSERO and did not plan to give the patient the 2nd dose of BEXSERO. Labs results were since returned to normal. The reporter agreed to follow up from GlaxoSmithKline.