chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood pressure decreased, Blood pressure increased, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Around 10am, my son complained of being very tired and laid on the couch. About 30 minutes later, he asked me to feel his chest and back. He was convulsing which I thought was a seizure. I took him across the street to ER where his BP was high. I believe 196/92. Then he started vomiting in the triage area. They moved us to a room. In that time, his BP dropped significantly and his fever rose to 103.7. After and IV of fluids and BENADRYL (i believe that was all that was given) he began to feel better and his symptoms subsided. His right arm was sore for a week. He is a basketball player and complained all week.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Seizure, Vomiting
Clinical narrative: Around 10am, my son complained of being very tired and laid on the couch. About 30 minutes later, he asked me to feel his chest and back. He was convulsing which I thought was a seizure. I took him across the street to ER where his BP was high. I believe 196/92. Then he started vomiting in the triage area. They moved us to a room. In that time, his BP dropped significantly and his fever rose to 103.7. After and IV of fluids and BENADRYL (i believe that was all that was given) he began to feel better and his symptoms subsided. His right arm was sore for a week. He is a basketball player and complained all week.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: On 12/1/2018 my left arm wasn't getting better at times I feel numbness in my hand and upper part of my arm it feels weakness, aches.
Age: 54.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Pyrexia, Swelling
Clinical narrative: When pt was called to remind to get next shot in series of SHINGRIX, pt stated not interested because had swelling, flu like symptoms, and fever of greater than 101.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pain, Peripheral swelling, Pruritus
Clinical narrative: Swollen deltoid with redness extending down to the elbow and warm to the touch. Significant Muscle soreness with throbbing pain the first evening. Itching.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Swollen deltoid with redness extending down to the elbow and warm to the touch. Significant Muscle soreness with throbbing pain the first evening. Itching.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Hardness at the site, redness, itchiness, pain.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site nodule
Clinical narrative: Patient came in complaining  of a knot on his arm at the location of the injection site for 3 weeks and is still there. It occured the day after his immunization. Patient states that he is going his doctor tomorrow to get it looked at and will call us and let us know what they say.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient came in 12/11/18 complaining that she had pain (soreness) in her arm for 2 weeks after the immunization. She no longer had the symptoms when she came in to tell us about it.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Pain at injection site the day of injection, but the pain lingered on and continues now. It is affecting the patient's activities of daily living. She has been using rest, ice, and ibuprofen without much relief. It is difficult for her to actively raise arm above shoulder height. To note, the patient and I work in the same clinic so we discussed her symptoms over the course of a few days. Her husband has been encouraging her to seek an evaluation for the pain, but she did not since she works in a clinic.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: Syncope x 1 minute, self resolved.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Site of injection on my arm is still causes pain 8 weeks later. Damage seems to be to my tricep muscle. Pain is primarily experienced when I move my arm a certain way but sometimes experienced when my arm is still. My personal trainer who I see weekly is a licensed physical therapist and has been working on this for 6 weeks but the pain is persisting.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash, Rash pruritic
Clinical narrative: Patient states she had a circular raised, itchy uncomfortable rash on her right upper leg/buttocks and down to her knee. She went to primary care md and they said it could be from her SHINGRIX shot she got and to have the pharmacy report. No treatment was given.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Bacterial test, Herpes virus test, Injection site rash, Rash
Clinical narrative: Rash on upper back both shoulders and both arms. Vaccine was given 11/14/18 reported by MD on 12/11/18.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Swelling face, Vaccination complication
Clinical narrative: Patient received one injection on each side about 4 pm on December 11, 2018. At about 9pm she noticed her face was swelling and she had some numbness. She didn't have any problems at injection sites other than normal soreness. She took TYLENOL PM because she knew there was BENADRYL in it. She slept all night. When she woke up it was more swollen and she said she looked like a cartoon character. She took BENADRYL at 8am and 10 am. She said swelling had gone down some. She had she takes flu shot every year and this was first SHINGRIX. I told her to call her physician to see if he wanted to see her. I called her back at 630pm and she said she had talked to MD and he felt like it was SHINGRIX vaccine and for her not take second one. He told her if she was still having trouble to call back in morning and he could give her a steroid shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Musculoskeletal pain
Clinical narrative: Patient complained about 4 hours after vaccine administration with significant pain in shoulder, pain worse than typical soreness, patient stated will be going to ER for evaluation, administering pharmacist said patient was moving and flexing muscle at time of administration.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Lethargy, Vomiting
Clinical narrative: Vomit, headache, dizzy, lethargic.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Within 1 minutes after receiving FLUZONE QUAD, the patient fell forward. The patient regained consciousness within a minute and did not remember the episode of fainting. The patient got bruise his forehead due to the hitting on the cabinet door. Ice pack was provided for his forehead. I and his father observed patient in the consultation room for 20 minutes. The patient is recovered completely and was able to walk out with his father.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Memory impairment, Syncope
Clinical narrative: Within 1 minutes after receiving FLUZONE QUAD, the patient fell forward. The patient regained consciousness within a minute and did not remember the episode of fainting. The patient got bruise his forehead due to the hitting on the cabinet door. Ice pack was provided for his forehead. I and his father observed patient in the consultation room for 20 minutes. The patient is recovered completely and was able to walk out with his father.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Heart rate increased, Injection site pain
Clinical narrative: Headache, chills, fever (99-100), muscle aches and pains, severe pain at injection site, dizziness, rapid heart beat. Symptoms lasted two days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Headache, chills, fever (99-100), muscle aches and pains, severe pain at injection site, dizziness, rapid heart beat. Symptoms lasted two days.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Injection site pain, Pyrexia
Clinical narrative: High Fever (102.7), Chills, Shivering, pain at injection site, headache, red face.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Redness, swelling at injection site. Pain in arm muscle not allowing movement passed shoulder. General tiredness, overall feeling blah. Headache that wouldn't go away even when ibuprofen taken 200 mg twice during the day.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Redness, swelling at injection site. Pain in arm muscle not allowing movement passed shoulder. General tiredness, overall feeling blah. Headache that wouldn't go away even when ibuprofen taken 200 mg twice during the day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Impaired driving ability, Injection site erythema, Injection site induration
Clinical narrative: 12 hours: swollen painful injection site, approx 1/4 inch raised, bright red, warm and hard to touch, about 2.5 inches in diameter, Day 2: same but now about 4 inches in diameter. Severe migraine (with related symptoms) lasting 24+ hours, muscle aches, queasy, spent day in bed, darkened bedroom, Day 3: injection site same, moderate to severe headache (not migraine) lasting 24 + hours, muscle aches, nausea, felt exhausted, spend day either in bed or in armchair in darkened bedroom, Day 4: injection site less swollen, still tender and warm, bright red. Mild headache, able to resume most activities except driving. Tired more easily than normal. Day 5: injection site improving, mild muscle aches only, mild headache. Fatigue. Day 6 to 8: Resume normal activities including driving with some mild aches and fatigue. Day 9 pretty much normal.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Loss of personal independence in daily activities, Migraine
Clinical narrative: 12 hours: swollen painful injection site, approx 1/4 inch raised, bright red, warm and hard to touch, about 2.5 inches in diameter, Day 2: same but now about 4 inches in diameter. Severe migraine (with related symptoms) lasting 24+ hours, muscle aches, queasy, spent day in bed, darkened bedroom, Day 3: injection site same, moderate to severe headache (not migraine) lasting 24 + hours, muscle aches, nausea, felt exhausted, spend day either in bed or in armchair in darkened bedroom, Day 4: injection site less swollen, still tender and warm, bright red. Mild headache, able to resume most activities except driving. Tired more easily than normal. Day 5: injection site improving, mild muscle aches only, mild headache. Fatigue. Day 6 to 8: Resume normal activities including driving with some mild aches and fatigue. Day 9 pretty much normal.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: 12 hours: swollen painful injection site, approx 1/4 inch raised, bright red, warm and hard to touch, about 2.5 inches in diameter, Day 2: same but now about 4 inches in diameter. Severe migraine (with related symptoms) lasting 24+ hours, muscle aches, queasy, spent day in bed, darkened bedroom, Day 3: injection site same, moderate to severe headache (not migraine) lasting 24 + hours, muscle aches, nausea, felt exhausted, spend day either in bed or in armchair in darkened bedroom, Day 4: injection site less swollen, still tender and warm, bright red. Mild headache, able to resume most activities except driving. Tired more easily than normal. Day 5: injection site improving, mild muscle aches only, mild headache. Fatigue. Day 6 to 8: Resume normal activities including driving with some mild aches and fatigue. Day 9 pretty much normal.
Age: 67.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Patient has experienced muscle and shoulder pain since the injection. She received BOOSTRIX on the same day in the other arm and it has been fine. Patient has had to seek medical treatment for the issue.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Patient has experienced muscle and shoulder pain following the immunization. He has had to seek medical treatment from his primary doctor and now an orthopedic
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Gait disturbance, Heart rate increased, Hyperhidrosis, Respiration abnormal
Clinical narrative: Late at night I started experiencing rapid heartbeat and could not calm that by shifting my breathing. I am skilled in meditation breathing techniques and I could make no progress, so I decided to get in a hot bath. On the way I had difficulty walking -- dizzy -- and did take that bath that immediately helped my heart calm down an my breathing became normal. I got up and went directly to bed; when I woke up at 6 am I was sweating and had a temperature of 99.8.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Headache, Influenza like illness
Clinical narrative: I had complete flu like symptoms: intense body aches, headache, chills, and general weakness. I stayed in bed for 2 days. I have had a dull pain in my upper abdomen, on the right side, under my ribcage, since then.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I had complete flu like symptoms: intense body aches, headache, chills, and general weakness. I stayed in bed for 2 days. I have had a dull pain in my upper abdomen, on the right side, under my ribcage, since then.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: HPV Vaccine was administered into the buttocks. No reaction noted.
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Chest pain, Diplegia
Clinical narrative: HPV Vaccine, On May 23rd 2017, I received the HPV vaccine. After the vaccine headaches and stomach pain followed. On June 23rd 2017 a month after the 1st HPV Shot, I experienced blood and mucus in my stool for three weeks straight the doctors did not have any answers. On June 7th 2017 I received the second HPV shot after receiving the second shot my life changed for the worse. I began to experience more stomach pain, chest pain, diarrhea with blood and more headaches. On September 4th 2017, 28 days after receiving the second shot my legs became paralyzed, I experienced severe joint pain in both of legs all night, I was unable to walk. I contacted my doctor to set an appointment took an x-ray later my doctor told me I have moderate left joint arthritis. I believed him and tried to work on my legs but doing Physical therapy hoping to get better in Time. Over a few months it has only got worse I've been to the doctors over and over this year with the hope I'll get better but each day it only get worse, my body is in so much pain. I've done multiple test and the recent test that I've done shows I now suffer from severe arthritis in my left leg I receive both shots in my left arm. I have emails to my doctors in detail about the Side effects I experienced after receiving the HPV Vaccine.
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Gait inability, Haematochezia, Headache, Monoplegia, Mucous stools
Clinical narrative: HPV Vaccine, On May 23rd 2017, I received the HPV vaccine. After the vaccine headaches and stomach pain followed. On June 23rd 2017 a month after the 1st HPV Shot, I experienced blood and mucus in my stool for three weeks straight the doctors did not have any answers. On June 7th 2017 I received the second HPV shot after receiving the second shot my life changed for the worse. I began to experience more stomach pain, chest pain, diarrhea with blood and more headaches. On September 4th 2017, 28 days after receiving the second shot my legs became paralyzed, I experienced severe joint pain in both of legs all night, I was unable to walk. I contacted my doctor to set an appointment took an x-ray later my doctor told me I have moderate left joint arthritis. I believed him and tried to work on my legs but doing Physical therapy hoping to get better in Time. Over a few months it has only got worse I've been to the doctors over and over this year with the hope I'll get better but each day it only get worse, my body is in so much pain. I've done multiple test and the recent test that I've done shows I now suffer from severe arthritis in my left leg I receive both shots in my left arm. I have emails to my doctors in detail about the Side effects I experienced after receiving the HPV Vaccine.
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Nerve conduction studies, Pain, X-ray abnormal
Clinical narrative: HPV Vaccine, On May 23rd 2017, I received the HPV vaccine. After the vaccine headaches and stomach pain followed. On June 23rd 2017 a month after the 1st HPV Shot, I experienced blood and mucus in my stool for three weeks straight the doctors did not have any answers. On June 7th 2017 I received the second HPV shot after receiving the second shot my life changed for the worse. I began to experience more stomach pain, chest pain, diarrhea with blood and more headaches. On September 4th 2017, 28 days after receiving the second shot my legs became paralyzed, I experienced severe joint pain in both of legs all night, I was unable to walk. I contacted my doctor to set an appointment took an x-ray later my doctor told me I have moderate left joint arthritis. I believed him and tried to work on my legs but doing Physical therapy hoping to get better in Time. Over a few months it has only got worse I've been to the doctors over and over this year with the hope I'll get better but each day it only get worse, my body is in so much pain. I've done multiple test and the recent test that I've done shows I now suffer from severe arthritis in my left leg I receive both shots in my left arm. I have emails to my doctors in detail about the Side effects I experienced after receiving the HPV Vaccine.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Mild blistering with redness, mildly painful, over area.
Age: 42.0
Sex: M
Vaccine: FLUC4, MMR, TDAP
Symptoms: Chills, Incorrect route of product administration, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: According to the VAERS form, MMR was given via intramuscular route but recommended to be given subcutaneously. She went to the doctor on 12/07/2018 for fever, chills, rash, lymphadenopathy of left axilla.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dry skin, Erythema, Pain, Peripheral swelling, Skin irritation
Clinical narrative: Redness, Swollen (L) arm 3.8 x 2.8, Pain, Dry skin/irritated, Hot to the touch. Took BENADRYL, Ice pack.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: Redness, Swollen (L) arm 3.8 x 2.8, Pain, Dry skin/irritated, Hot to the touch. Took BENADRYL, Ice pack.
Age: 97.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Vaccination complication
Clinical narrative: SHINGRIX vaccine has produced an adverse reaction of severe itching.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Diarrhoea, Headache, Myalgia, Pyrexia
Clinical narrative: Fevers, chills, muscle aches, headache, diarrhea Friday night 11/23; Saturday 11/24; Sunday morning 11/25.
Age: 86.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pt called on 12-10-18 and said that left arm had been hurting since she got the shot and was getting progressively worse and going down (L) arm and up her neck. She said skin did not look swollen or abnormal. Nurse told her to see Dr. ASAP.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt arm at injection site is red and swollen. Injection site is warm/hot to touch. More than 8cm diameter.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Painful during injection and pain continued weeks after. Still painful when raising arms overhead/move arms laterally.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Pain, erythema, pruritus to (L) upper arm x 3 weeks. KEFLEX 500mg TID x 10 days, Prednisone 40mg QDx5 days.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: Slight fever, chills, fatigue, shaking, headache across forehead. All lasting 2 days then 1 more day slowly back to normal.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Head injury, Loss of consciousness, Lower limb fracture, Nausea
Clinical narrative: Pt was queasy, blacked out, fell. Hit head on doorframe, comp. fract. of back, leg on doorframe. Called ambulance. Hospital wanted her to stay, she didn't.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer refers to a 12 year old non-pregnant female patient. The patient's chronic or long-standing health conditions were reported as none. The patient was allergic to red food dye. On 04-AUG-2017, the patient was vaccinated with GARDASIL 9, (strength, dose, lot # and expiry date were not reported) via intramuscular route for prophylaxis. On 07-AUG-2017, the patient had red, hot, swollen and painful injection site. The outcome of vaccination site erythema, vaccination site warmth, vaccination site swelling and vaccination site pain was reported as not recovered/not resolved. Causality assessment was not reported.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Laboratory test, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, fever and bedridden. On an unknown date, the outcome of the shivering, fever and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, fever and bedridden to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for himself. The age at vaccination was not reported but it could be 63 or 64 years. The next day after receiving SHINGRIX, the patient experienced shivering, rigor, fever and had to go to bed which lasted for a couple of days. The physician consented to follow up. For tolerance to the 2nd dose of SHINGRIX refer case US2018GSK223469, for the same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, fever and bedridden. On an unknown date, the outcome of the shivering, fever and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, fever and bedridden to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for himself. The age at vaccination was not reported but it could be 63 or 64 years. The next day after receiving SHINGRIX, the patient experienced shivering, rigor, fever and had to go to bed which lasted for a couple of days. The physician consented to follow up. For tolerance to the 2nd dose of SHINGRIX refer case US2018GSK223469, for the same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Chills, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, fever and bedridden. On an unknown date, the outcome of the shivering, fever and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, fever and bedridden to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for himself. The age at vaccination was not reported but it could be 63 or 64 years. The next day after receiving SHINGRIX, the patient experienced shivering, rigor, fever and had to go to bed which lasted for a couple of days. The physician consented to follow up. For tolerance to the 2nd dose of SHINGRIX refer case US2018GSK223469, for the same patient.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: This spontaneous report was received from a 67-year-old retired nurse reporting about herself. The patient's medical history was not reported. The patient had allergy to sulpha drugs which lead to hives. The patient's concurrent conditions were not reported. Concomitant therapies included metoprolol tartrate. On 29-NOV-2018 at 18:00 PM, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot # and expiry date were not reported) intramuscularly for prevention of pneumonia (prophylaxis). On 29-NOV-2018, a few hours later the patient experienced injection site redness and sore. On 30-NOV-2018 (the next morning), the patient experienced redness from just below the injection site down to near the elbow and the redness spread throughout the day down to near the wrist. The patient's arm swelled terribly, was red hard and looked like cellulitis. The patient experienced malaise, headache and nausea and the patient was unable to complete normal daily tasks due to malaise and pain. On 03-DEC-2018, the patient reported that swelling was reduced. On an unknown date, the patient was treated with elevation, ibuprofen and heat/ice for the events. On an unknown date, the patient sought medical attention by a physician who was a family member. Outcome of malaise, generalized erythema, nausea, injection site pain, injection site erythema, headache, oedema and pain were reported as recovering. Causality assessment was not provided. The reporter considered the events malaise and pain was serious due to disability. Upon internal review the event cellulitis was consider to be medically significant.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Headache, Induration, Injection site erythema
Clinical narrative: This spontaneous report was received from a 67-year-old retired nurse reporting about herself. The patient's medical history was not reported. The patient had allergy to sulpha drugs which lead to hives. The patient's concurrent conditions were not reported. Concomitant therapies included metoprolol tartrate. On 29-NOV-2018 at 18:00 PM, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot # and expiry date were not reported) intramuscularly for prevention of pneumonia (prophylaxis). On 29-NOV-2018, a few hours later the patient experienced injection site redness and sore. On 30-NOV-2018 (the next morning), the patient experienced redness from just below the injection site down to near the elbow and the redness spread throughout the day down to near the wrist. The patient's arm swelled terribly, was red hard and looked like cellulitis. The patient experienced malaise, headache and nausea and the patient was unable to complete normal daily tasks due to malaise and pain. On 03-DEC-2018, the patient reported that swelling was reduced. On an unknown date, the patient was treated with elevation, ibuprofen and heat/ice for the events. On an unknown date, the patient sought medical attention by a physician who was a family member. Outcome of malaise, generalized erythema, nausea, injection site pain, injection site erythema, headache, oedema and pain were reported as recovering. Causality assessment was not provided. The reporter considered the events malaise and pain was serious due to disability. Upon internal review the event cellulitis was consider to be medically significant.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Malaise, Nausea, Pain
Clinical narrative: This spontaneous report was received from a 67-year-old retired nurse reporting about herself. The patient's medical history was not reported. The patient had allergy to sulpha drugs which lead to hives. The patient's concurrent conditions were not reported. Concomitant therapies included metoprolol tartrate. On 29-NOV-2018 at 18:00 PM, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot # and expiry date were not reported) intramuscularly for prevention of pneumonia (prophylaxis). On 29-NOV-2018, a few hours later the patient experienced injection site redness and sore. On 30-NOV-2018 (the next morning), the patient experienced redness from just below the injection site down to near the elbow and the redness spread throughout the day down to near the wrist. The patient's arm swelled terribly, was red hard and looked like cellulitis. The patient experienced malaise, headache and nausea and the patient was unable to complete normal daily tasks due to malaise and pain. On 03-DEC-2018, the patient reported that swelling was reduced. On an unknown date, the patient was treated with elevation, ibuprofen and heat/ice for the events. On an unknown date, the patient sought medical attention by a physician who was a family member. Outcome of malaise, generalized erythema, nausea, injection site pain, injection site erythema, headache, oedema and pain were reported as recovering. Causality assessment was not provided. The reporter considered the events malaise and pain was serious due to disability. Upon internal review the event cellulitis was consider to be medically significant.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a 67-year-old retired nurse reporting about herself. The patient's medical history was not reported. The patient had allergy to sulpha drugs which lead to hives. The patient's concurrent conditions were not reported. Concomitant therapies included metoprolol tartrate. On 29-NOV-2018 at 18:00 PM, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot # and expiry date were not reported) intramuscularly for prevention of pneumonia (prophylaxis). On 29-NOV-2018, a few hours later the patient experienced injection site redness and sore. On 30-NOV-2018 (the next morning), the patient experienced redness from just below the injection site down to near the elbow and the redness spread throughout the day down to near the wrist. The patient's arm swelled terribly, was red hard and looked like cellulitis. The patient experienced malaise, headache and nausea and the patient was unable to complete normal daily tasks due to malaise and pain. On 03-DEC-2018, the patient reported that swelling was reduced. On an unknown date, the patient was treated with elevation, ibuprofen and heat/ice for the events. On an unknown date, the patient sought medical attention by a physician who was a family member. Outcome of malaise, generalized erythema, nausea, injection site pain, injection site erythema, headache, oedema and pain were reported as recovering. Causality assessment was not provided. The reporter considered the events malaise and pain was serious due to disability. Upon internal review the event cellulitis was consider to be medically significant.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 22 years old female patient. The patient's obstetric history included two previous pregnancies, one full term delivery and one spontaneous abortion (SAB) (miscarriage). The patient's concurrent medical conditions were not reported. Date of last menstrual period (LMP) was reported as 27-OCT-2018 and estimated delivery date (EDD) as 03-AUG-2019. At the time of the report, pregnancy outcome was pending. On 12-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # N022728, expiration date 31-MAY-2020 (route of administration was not reported) for prophylaxis. Concomitant therapies included ethinyl estradiol (+) norgestimate(SPRINTEC). Gestation period at exposure to GARDASIL 9 was at 2 weeks.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 22 years old female patient. The patient's obstetric history included two previous pregnancies, one full term delivery and one spontaneous abortion (SAB) (miscarriage). The patient's concurrent medical conditions were not reported. Date of last menstrual period (LMP) was reported as 27-OCT-2018 and estimated delivery date (EDD) as 03-AUG-2019. At the time of the report, pregnancy outcome was pending. On 12-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # N022728, expiration date 31-MAY-2020 (route of administration was not reported) for prophylaxis. Concomitant therapies included ethinyl estradiol (+) norgestimate(SPRINTEC). Gestation period at exposure to GARDASIL 9 was at 2 weeks.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient received hepatitis A vaccination on 10/3/18 at work in the right upper extremity. States that at first the area swelled to the size of a small knot, but has worsened over the last 2-3 weeks. Patient states he has been treated with steroids and Bactrim with no relief. States that the area has increased in size. Rates pain in the right upper extremity near the deltoid as a 8-9/10. States the pain radiates up to the right shoulder and down to the right elbow. Denies fever, chills, sweats, drainage. Never had anything like this before. I&D performed.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Patient received hepatitis A vaccination on 10/3/18 at work in the right upper extremity. States that at first the area swelled to the size of a small knot, but has worsened over the last 2-3 weeks. Patient states he has been treated with steroids and Bactrim with no relief. States that the area has increased in size. Rates pain in the right upper extremity near the deltoid as a 8-9/10. States the pain radiates up to the right shoulder and down to the right elbow. Denies fever, chills, sweats, drainage. Never had anything like this before. I&D performed.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Arthralgia, Corynebacterium test positive, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received hepatitis A vaccination on 10/3/18 at work in the right upper extremity. States that at first the area swelled to the size of a small knot, but has worsened over the last 2-3 weeks. Patient states he has been treated with steroids and Bactrim with no relief. States that the area has increased in size. Rates pain in the right upper extremity near the deltoid as a 8-9/10. States the pain radiates up to the right shoulder and down to the right elbow. Denies fever, chills, sweats, drainage. Never had anything like this before. I&D performed.
Age: 40.0
Sex: M
Vaccine: FLU3, HEPA, PPV, UNK
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Patient reports pain and redness both arms after receiving vaccinations 10-3-18.
Age: 40.0
Sex: M
Vaccine: FLU3, HEPA, PPV, UNK
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reports pain and redness both arms after receiving vaccinations 10-3-18.
Age: 44.0
Sex: M
Vaccine: FLU4, HEPA, PPV, UNK
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Patient reports red inflamed knots appeared on both arms after vaccinations.
Age: 44.0
Sex: M
Vaccine: FLU4, HEPA, PPV, UNK
Symptoms: Tenderness
Clinical narrative: Patient reports red inflamed knots appeared on both arms after vaccinations.
Age: 44.0
Sex: M
Vaccine: FLU4, HEPA, PPV, UNK
Symptoms: Erythema, Inflammation, Nodule
Clinical narrative: Patient reports red inflamed knots appeared on both arms after vaccinations.
Age: 9.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of hives in a 9-year-old female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 23rd November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 23rd November 2018, less than an hour after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced hives and localized itching. On an unknown date, the outcome of the hives and localized itching were not recovered/not resolved. It was unknown if the reporter considered the hives and localized itching to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient broke out with itchy feet and hives that continued with outbreak of hives through 28th November 2018. The reporter was agree to follow up from GlaxoSmithKline.
Age: 9.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of hives in a 9-year-old female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 23rd November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 23rd November 2018, less than an hour after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced hives and localized itching. On an unknown date, the outcome of the hives and localized itching were not recovered/not resolved. It was unknown if the reporter considered the hives and localized itching to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient broke out with itchy feet and hives that continued with outbreak of hives through 28th November 2018. The reporter was agree to follow up from GlaxoSmithKline.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Bacterial test negative, Erythema, Inflammation, Mass excision, Nodule
Clinical narrative: Patient reported an area that appeared a few days after her vaccination that looked like a black head. The area gradually became larger and red with swelling and pain
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Tenderness
Clinical narrative: Patient reported an area that appeared a few days after her vaccination that looked like a black head. The area gradually became larger and red with swelling and pain
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Acne, Erythema, Pain, Swelling
Clinical narrative: Patient reported an area that appeared a few days after her vaccination that looked like a black head. The area gradually became larger and red with swelling and pain
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Peripheral swelling
Clinical narrative: Patient reported an area that appeared a few days after her vaccination that looked like a black head. The area gradually became larger and red with swelling and pain
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Acne, Culture negative, Erythema, Fungal test
Clinical narrative: Patient reported an area that appeared a few days after her vaccination that looked like a black head. The area gradually became larger and red with swelling and pain
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Incisional drainage, Mycobacterium test negative, Pain, Pain in extremity, Swelling
Clinical narrative: Patient reported an area that appeared a few days after her vaccination that looked like a black head. The area gradually became larger and red with swelling and pain
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Bacterial test negative, Erythema, Inflammation, Mass excision, Nodule
Clinical narrative: Patient presented to our office after adverse reaction from flu shot given at her work place, she had abscess on right upper arm and swelling.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Tenderness
Clinical narrative: Patient presented to our office after adverse reaction from flu shot given at her work place, she had abscess on right upper arm and swelling.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Acne, Erythema, Pain, Swelling
Clinical narrative: Patient presented to our office after adverse reaction from flu shot given at her work place, she had abscess on right upper arm and swelling.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Peripheral swelling
Clinical narrative: Patient presented to our office after adverse reaction from flu shot given at her work place, she had abscess on right upper arm and swelling.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Acne, Culture negative, Erythema, Fungal test
Clinical narrative: Patient presented to our office after adverse reaction from flu shot given at her work place, she had abscess on right upper arm and swelling.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Incisional drainage, Mycobacterium test negative, Pain, Pain in extremity, Swelling
Clinical narrative: Patient presented to our office after adverse reaction from flu shot given at her work place, she had abscess on right upper arm and swelling.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash generalised
Clinical narrative: Rash covering full body and face. Did not bother him too much but he was covered. 5 days.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dehydration, Exposure during pregnancy, Full blood count, Hallucination
Clinical narrative: EDD: 01/18/2019 I developed an uncontrolled fever, hallucinations, body aches, joint pains, stiff neck, TMJ, due to this when I went to labor and delivery I was told I'm severely dehydrated and it is causing contractions. Iron and prenatals.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Temporomandibular joint syndrome, Uterine contractions during pregnancy
Clinical narrative: EDD: 01/18/2019 I developed an uncontrolled fever, hallucinations, body aches, joint pains, stiff neck, TMJ, due to this when I went to labor and delivery I was told I'm severely dehydrated and it is causing contractions. Iron and prenatals.
Age: 34.0
Sex: M
Vaccine: HEPAB, RAB
Symptoms: Anger, Discomfort, Dysgeusia, Emotional distress, Gait disturbance
Clinical narrative: 8 hours after my TWINRIX and rabies second vaccine. I started having Starburst open eyed visuals then got sick. Progressively sicker for 5 days then at day six I think I almost died. Hr was at 120+ body temperature high, extreme anger, difficulty walking, thinking, and talking. I figured my body went through the throws of almost dying from rabies. Figured it would be a one time thing. However, since then. It happens about once a month or more frequently recently. Accompanied with the same metallic taste in my mouth that I feel as burning pain especially where I have severed and exposed tongue nerves in my inner gumline through to my tongue. The degree of pain, discomfort, anger, and paranoia it brings with it is almost completely unbearable. Occasionally I will have small seizures at the worst point. If I did not grow up in abuse. I do not think I could have survived the anger, paranoia, and emotional stress of feeling like your dying. I have to use to much ibuprofen. I think I would have died without it a few times. Especially, the first week. So, getting proper medicine is impossible. I should have 500mgib prophen/20mgoxycodone x20 and 60 VALIUM 10mg.
Age: 34.0
Sex: M
Vaccine: HEPAB, RAB
Symptoms: Malaise, Mental impairment, Pain, Paranoia, Pyrexia
Clinical narrative: 8 hours after my TWINRIX and rabies second vaccine. I started having Starburst open eyed visuals then got sick. Progressively sicker for 5 days then at day six I think I almost died. Hr was at 120+ body temperature high, extreme anger, difficulty walking, thinking, and talking. I figured my body went through the throws of almost dying from rabies. Figured it would be a one time thing. However, since then. It happens about once a month or more frequently recently. Accompanied with the same metallic taste in my mouth that I feel as burning pain especially where I have severed and exposed tongue nerves in my inner gumline through to my tongue. The degree of pain, discomfort, anger, and paranoia it brings with it is almost completely unbearable. Occasionally I will have small seizures at the worst point. If I did not grow up in abuse. I do not think I could have survived the anger, paranoia, and emotional stress of feeling like your dying. I have to use to much ibuprofen. I think I would have died without it a few times. Especially, the first week. So, getting proper medicine is impossible. I should have 500mgib prophen/20mgoxycodone x20 and 60 VALIUM 10mg.
Age: 34.0
Sex: M
Vaccine: HEPAB, RAB
Symptoms: Seizure, Speech disorder, Visual impairment
Clinical narrative: 8 hours after my TWINRIX and rabies second vaccine. I started having Starburst open eyed visuals then got sick. Progressively sicker for 5 days then at day six I think I almost died. Hr was at 120+ body temperature high, extreme anger, difficulty walking, thinking, and talking. I figured my body went through the throws of almost dying from rabies. Figured it would be a one time thing. However, since then. It happens about once a month or more frequently recently. Accompanied with the same metallic taste in my mouth that I feel as burning pain especially where I have severed and exposed tongue nerves in my inner gumline through to my tongue. The degree of pain, discomfort, anger, and paranoia it brings with it is almost completely unbearable. Occasionally I will have small seizures at the worst point. If I did not grow up in abuse. I do not think I could have survived the anger, paranoia, and emotional stress of feeling like your dying. I have to use to much ibuprofen. I think I would have died without it a few times. Especially, the first week. So, getting proper medicine is impossible. I should have 500mgib prophen/20mgoxycodone x20 and 60 VALIUM 10mg.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Low grade fever (99-100 degrees), flu like aches, soreness Spent 12/11/2018 in bed most the day.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pain in extremity, Pyrexia, Thinking abnormal
Clinical narrative: Really sore arm, could not sleep my mind was like in a dream, over and over the same thoughts. Had to have fever and was shivering. If I had known this was going to happen I would not have gotten the shot.