chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUR4
Symptoms: Throat tightness
Clinical narrative: This is an initial report of a serious adverse event, received on 17/Oct/2014, by a 35-year-old female patient/consumer. The patient received FLUBLOK TRIVALENT Intramuscular on 17/Oct/2014 at an unknown location. The patient developed an immediate reaction of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath (SOB), all of which resulted in an emergency room visit. The duration of the events was 0 days and all of the events were considered recovered. Medical/surgical history reported no known drug allergy (NKDA) and egg allergy. Any illnesses at the time of vaccination were not reported. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported. This report was received from a consumer therefore; no medical confirmation or assessment of causality is available. Further information is unavailable at the time of this report. The Company's assessment of the causal relationship between these events and FLUBLOK is that there may be a possible relationship based on the reported information that the reactions of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath occurred immediately after post injection. Addendum: significant correction was performed on 28-DEC-2018 to correct product FLUBLOK TRIVALENT (528) from FLUBLOK QIV (529). Sender's Comments: This case concerns a 35 years old patient who developed an immediate reaction of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath. Time to onset is compatible. Etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 86.0
Sex: F
Vaccine: FLUR3
Symptoms: Influenza, Pneumonia
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK TRIVALENT (528). Initial solicited report received on 01 April 2016 from an investigator participating in a study. This case involves a 86-years-old female subject who had Influenza and pneuminia during the study participation. The subject's medical history was not reported. The subject concomitant therapy was not reported. On 29 September 2015, same day after receiving a intramuscular dose of FLUBLOK TIV vaccine in arm on 29 September 2015 (batch number 550653F), the patient developed Influenza and pneuminia. The event was considered as life-threatening. It was reported that the subject had influenza and pneumonia. The lab data was not reported. Corrective treatment was not reported. The outcome of the events was reported as unknown. Relationship to investigational product according to reporter: related. Relationship to investigational product according to company: reportable. List of documents held by sender: none. Addendum 31 Dec 2018. Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK TRIVALENT (528).; Sender's Comments: The same day of receiving TIV patient had influenza and pneumonia hence temporal relation not plausible. Based on limited data available role of vaccine can not be assessed.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Pruritus
Clinical narrative: Left bicep with pulsing/achy/burning/itching pain at a level of 3-4 on pain scale 1-10. Started around 5 pm on the day after injection with gradually increasing intensity -- radiating to below elbow and to shoulder. Difficult to preform activities of daily living at this time. Did see Dr. at Employee Health today. Started a methylprednisolone 4mg taper and will follow-up on 1/11/2019.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Apathy, Asthenia, Chest discomfort, Chills
Clinical narrative: This was dose #2; I had not had a reaction to dose #1, which was 6 months earlier. The shot was at about 7 pm. The shot hurt just slightly for a few seconds and then was fine. The BENADRYL was making me drowsy as expected, but about an hour later, I just kept getting more and more drowsy until I fell asleep in my chair. (That might have still just been the BENADRYL although it hasn't made me THAT drowsy before.) I trudged upstairs and collapsed in the bed. I tried to get up the next morning and just couldn't because I was so out of it, had just a little congestion, and tried getting up for real about 11 am feeling tired. I took a shower hoping that would help, went downstairs and tried eating a few bites of a banana, and started spiraling downhill: chills, sweating, weakness, tingling skin, aches in general, and then started feeling like I was about to black out. I went upstairs and almost threw up, felt like blacking out again, had a little chest tightness. I fell into bed again, slept until about 1:30 pm, got up and felt a little better but very weak. Over the next 2 hours, it pretty much completely went away; I was just a little lacking in motivation for the rest of the day. Then I was pretty much back to normal, so that was not a real flu that I just happened to get by coincidence.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: This was dose #2; I had not had a reaction to dose #1, which was 6 months earlier. The shot was at about 7 pm. The shot hurt just slightly for a few seconds and then was fine. The BENADRYL was making me drowsy as expected, but about an hour later, I just kept getting more and more drowsy until I fell asleep in my chair. (That might have still just been the BENADRYL although it hasn't made me THAT drowsy before.) I trudged upstairs and collapsed in the bed. I tried to get up the next morning and just couldn't because I was so out of it, had just a little congestion, and tried getting up for real about 11 am feeling tired. I took a shower hoping that would help, went downstairs and tried eating a few bites of a banana, and started spiraling downhill: chills, sweating, weakness, tingling skin, aches in general, and then started feeling like I was about to black out. I went upstairs and almost threw up, felt like blacking out again, had a little chest tightness. I fell into bed again, slept until about 1:30 pm, got up and felt a little better but very weak. Over the next 2 hours, it pretty much completely went away; I was just a little lacking in motivation for the rest of the day. Then I was pretty much back to normal, so that was not a real flu that I just happened to get by coincidence.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Respiratory tract congestion, Somnolence
Clinical narrative: This was dose #2; I had not had a reaction to dose #1, which was 6 months earlier. The shot was at about 7 pm. The shot hurt just slightly for a few seconds and then was fine. The BENADRYL was making me drowsy as expected, but about an hour later, I just kept getting more and more drowsy until I fell asleep in my chair. (That might have still just been the BENADRYL although it hasn't made me THAT drowsy before.) I trudged upstairs and collapsed in the bed. I tried to get up the next morning and just couldn't because I was so out of it, had just a little congestion, and tried getting up for real about 11 am feeling tired. I took a shower hoping that would help, went downstairs and tried eating a few bites of a banana, and started spiraling downhill: chills, sweating, weakness, tingling skin, aches in general, and then started feeling like I was about to black out. I went upstairs and almost threw up, felt like blacking out again, had a little chest tightness. I fell into bed again, slept until about 1:30 pm, got up and felt a little better but very weak. Over the next 2 hours, it pretty much completely went away; I was just a little lacking in motivation for the rest of the day. Then I was pretty much back to normal, so that was not a real flu that I just happened to get by coincidence.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Night sweats, Pyrexia
Clinical narrative: Client developed redness, warmth at injection site within 24 hours. He also developed a lowgrade fever. He called clinic and spoke to this RN who instructed him to draw line with pen around redness and go to nearest ER or urgent care b/c it sounded like Cellulitis. Client went to urgent care and was started on oral KEFLEX 500 mg. After 2 doses of KEFLEX, client returned to clinic and redness and warmth had gotten worse. Pt reported night sweats as well and fatigue. Dr. (medical director) assessed client at this time (1/4/19). Client did not want to go to ER due to lack of insurance. Dr. ordered 500 mg ROCEPHIN IM to be given and to go to ER if symptoms worsened over weekend. Client verbalized understanding. ROCEPHIN given IM into left deltoid by this RN.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Employee states that the muscle in her arm became sore the evening after receiving her vaccine on 12/18/18. She states that the pain continues and is intermittent, described as feeling like a "charlie horse" in her muscle. There are no complaints of redness, pain or swelling at the site, no fever, no numbness. Employee states that the pain comes and goes, and is "deep" in the muscle, just not improving with time or use of Tylenol or Ibuprofen. I consulted with the hospital's pharmacist and epidemiologist. The employee was encouraged to follow-up with her physician.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient came in to the pharmacy on 12/28/2018 and complained that he has been having pain in his left arm since he got the flu shot on 11/05/2018. He has tried pain medication but it did not help him. He also said that his left arm is painful and he has to use the right arm to lift his left arm. When asked if he has seen his doctor, he said that he has high deductible and did not see his doctor.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Inadequate aseptic technique in use of product, Pain in extremity, Peripheral swelling, Rash pustular, Secretion discharge
Clinical narrative: Pt was given 2 shots on or about 10/3/2018. Pt states she received a hepatitis A shot and flu shot but unsure which she receive in each arm. Pt reports having pain and swelling in R arm x 6weeks. Pt reports having pain and moderate pus discharge from L arm that lasted a few days and has since healed up. Pt reports to office today because she was notified by work she needed additional workup for issues. Pt describes receiving shots with at least 7 other individuals and states person giving vaccine didn't change gloves between them. She didn't think anything about it until everyone started having issues. Issue is still ongoing.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis, Injection site pain, Pain in extremity
Clinical narrative: Patient received vaccine on 12/3/18 and reported to primary care Dr. on 12/7/18 at 9:20am that he had developed cellulitis and pain all the way down to his fingers from the injection site of his left arm. I tried reaching patient twice on 12/16 @7:05pm and 12/29/18 @10:15am to see how he was doing and got hung up on both times. Filed a report via Agency on 12/31/18.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian- Barre.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: Per patient representative. Patient developed cellulitis (red, inflamed) and was treated with antibiotics.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Pain
Clinical narrative: Vaccine into shoulder joint causing pain, limited range of motion unresolved over a month. Prednisone injection and physical therapy. Limited range of motion, aching, and nocturnal pain continues to present (1/4/2019).
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood test, Computerised tomogram, Dysstasia, Electrocardiogram, Electroencephalogram
Clinical narrative: Tired and not feeling well 101318 - by Monday, 101518, started feeling tingling in hands, progressed and was out of work few days between 101518 and 110218. Sunday, 110418 was walking very wobbly and unstable and hands and feet were numbing more. By Monday, 110518 - no longer able to walk or stand. Admitted to via ER visit.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Gait disturbance, Gait inability, Hypoaesthesia, Impaired work ability
Clinical narrative: Tired and not feeling well 101318 - by Monday, 101518, started feeling tingling in hands, progressed and was out of work few days between 101518 and 110218. Sunday, 110418 was walking very wobbly and unstable and hands and feet were numbing more. By Monday, 110518 - no longer able to walk or stand. Admitted to via ER visit.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Malaise, Nuclear magnetic resonance imaging, Paraesthesia, X-ray
Clinical narrative: Tired and not feeling well 101318 - by Monday, 101518, started feeling tingling in hands, progressed and was out of work few days between 101518 and 110218. Sunday, 110418 was walking very wobbly and unstable and hands and feet were numbing more. By Monday, 110518 - no longer able to walk or stand. Admitted to via ER visit.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: 99.7 temperature.
Age: 25.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt was given flu shot first in upper left arm. No problems. Pt was given HAVRIX in same arm about 2 inches lower. After RPh removed the syringe, he stated "that made me light headed". He stopped talking and started to slump in chair. RPh immediately called for help, another RPh entered the vaccine room. He was unresponsive for about 30 seconds and got very pale. As the RPh's rubbed his back and tried to rouse him, he seemed to be coming around, but still confused for several minutes. He then pointed to trash can, and vomited. Afterward, he seemed less confused and his color returned. We offered water and paper towels. He sipped on the water and seemed to be recovering. Offered to call his wife (who was in the car). He denied. We checked his BP and it was about 140/85 and pulse was about 90. He stayed in clinical room about 10 minutes total. RPh walked him to his car and asked his wife to drive him home. He stated he was feeling "fine".
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reported she was experiencing pain in her administration arm shortly after receiving the vaccination. She had full range of motion, but noted it was painful to move her arm. The pain was localized to the upper arm/shoulder area. It did not seem to be tender to touch, but was affected with movement of her arm at the shoulder joint.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site papule, Injection site rash, Joint lock, Muscular weakness, Neuropathy peripheral
Clinical narrative: Per patient recollection of events. The night post vaccination he experienced a round mark of bumps/papules around the injection site along with pain described as "being hit in the arm with a baseball bat." Patient then stated he had peripheral neuropathy of both legs for 1 month. He saw an orthopedic doctor and had an x-ray which turned up negative for any issues. He states that he does have a history of arthritis in his right knee but this was unrelated. October 29th he experienced weakness in the knees again and it locked. He went through 5 weeks of physical therapy per his doctor's recommendation but saw no improvement in his symptoms. Patient is also a pediatric doctor.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Per patient recollection of events. The night post vaccination he experienced a round mark of bumps/papules around the injection site along with pain described as "being hit in the arm with a baseball bat." Patient then stated he had peripheral neuropathy of both legs for 1 month. He saw an orthopedic doctor and had an x-ray which turned up negative for any issues. He states that he does have a history of arthritis in his right knee but this was unrelated. October 29th he experienced weakness in the knees again and it locked. He went through 5 weeks of physical therapy per his doctor's recommendation but saw no improvement in his symptoms. Patient is also a pediatric doctor.
Age: 66.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Neuralgic amyotrophy, Radiculitis brachial
Clinical narrative: BRACHIAL NEURITIS, PARSONAGE-TURNER SYNDROME.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the pharmacy on 01/04/19 and stated that she possible had an allergic reaction to the vaccine she stated that her arm was warm developed a red rash as well as a small bump around the site of injection a some further down the arm. I told the patient to keep an eye on the rash and to take 1-2 BENADRYL every 4-6 hours until the rash resolved. If the rash got worse or continued to spread I told her to go to urgent care or the ER immediately
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Biopsy, Blood test, Erythema, Joint swelling, Peripheral swelling
Clinical narrative: Patient states the day after the shot she developed a rash on one leg and her ankle became swollen. She went to the urgent care and was given an antibiotic. They said it was not the flu shot but if gets worse, to go to dermatologist. Patient went to dermatologist today and she said she cannot rule out that it is not due to the flu shot. Patient has rash on both legs, arms (large red welts) and left foot is completely swollen. MD took biopsy and prescribed steroids and blood work.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash, Urticaria
Clinical narrative: Patient states the day after the shot she developed a rash on one leg and her ankle became swollen. She went to the urgent care and was given an antibiotic. They said it was not the flu shot but if gets worse, to go to dermatologist. Patient went to dermatologist today and she said she cannot rule out that it is not due to the flu shot. Patient has rash on both legs, arms (large red welts) and left foot is completely swollen. MD took biopsy and prescribed steroids and blood work.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on back and spreading to limbs.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Autopsy, Constipation, Death, Hypersomnia, Somnolence
Clinical narrative: Sleepiness-12/10/18-12/16/18 slept more than usual. No bowel movement-poop 12/10/18-12/16/18 Death, SIDS 7:32am on December 16th 2018.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Sudden infant death syndrome, Toxicologic test
Clinical narrative: Sleepiness-12/10/18-12/16/18 slept more than usual. No bowel movement-poop 12/10/18-12/16/18 Death, SIDS 7:32am on December 16th 2018.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Pathology test, Toxicologic test
Clinical narrative: Sleepiness-12/10/18-12/16/18 slept more than usual. No bowel movement-poop 12/10/18-12/16/18 Death, SIDS 7:32am on December 16th 2018.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Autopsy, Constipation, Death, Hypersomnia, Somnolence
Clinical narrative: Infant was found dead at home on 12/17/18 and taken to Hospital and pronounced there and was then followed by Coroner.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Sudden infant death syndrome, Toxicologic test
Clinical narrative: Infant was found dead at home on 12/17/18 and taken to Hospital and pronounced there and was then followed by Coroner.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Pathology test, Toxicologic test
Clinical narrative: Infant was found dead at home on 12/17/18 and taken to Hospital and pronounced there and was then followed by Coroner.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Reddened area to (L) deltoid; warm to touch; painful. Measured 94x66 cm redness. Shot given 1/2/19, symptoms 1/3/19. Prescribed BACTRIM and prednisone.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Impaired work ability, Mobility decreased, Pain
Clinical narrative: The next morning 11/11/18 - Legs were hurting and all my joints, I couldn't move, went to church, the pain was very severe. I drove myself to ER - told Dr. received - SHINGRIX shot day before, took blood test, IV. I was in so much pain - gave me pain in IV. Doctor said that's all she could do. Drove home still in pain - I couldn't walk. I did make it home. Had to take 2 days off, all my joints was so painful, also. I still could not walk. I still get pain in my joints - continually I feel this is from the shot. No one can tell me how long it will last.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The next morning 11/11/18 - Legs were hurting and all my joints, I couldn't move, went to church, the pain was very severe. I drove myself to ER - told Dr. received - SHINGRIX shot day before, took blood test, IV. I was in so much pain - gave me pain in IV. Doctor said that's all she could do. Drove home still in pain - I couldn't walk. I did make it home. Had to take 2 days off, all my joints was so painful, also. I still could not walk. I still get pain in my joints - continually I feel this is from the shot. No one can tell me how long it will last.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Ear swelling, Injection site warmth, Peripheral swelling, Swelling
Clinical narrative: Pt received Pneumococcal vaccine at 8:50AM on 1/3/19. Pt called in at 9:30am on 1/4/19 experiencing swelling in arm, shoulder, ear and back of neck. Inj site is warm to touch Pt going to urgent care to rule out cellulitis.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Hypophagia, Lethargy, Nuclear magnetic resonance imaging brain
Clinical narrative: 12/24 /18 - Admitted to hospital for increasing lethargy and poor PO intake. Developed ataxic gait and truncal ataxia on ~12/26-27; Diagnosed with ADEM  on 12/28/18 and started on high dose steroids.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging spinal
Clinical narrative: 12/24 /18 - Admitted to hospital for increasing lethargy and poor PO intake. Developed ataxic gait and truncal ataxia on ~12/26-27; Diagnosed with ADEM  on 12/28/18 and started on high dose steroids.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Muscle aches, headache, nausea, fatigue, possible fever.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Gait inability, Injection site pain, Pyrexia
Clinical narrative: Severe shivering with inability to walk for 20 minutes. Fever. Soreness at site. Shivering subsided after 30 minutes. Fever persisted for several hours. Took ibuprofen for soreness & fever with good outcome.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The pharmacist gave me this shot subcutaneous when it is supposed to be an IM. As a result I have had significant swelling, itching and pain at the site of the injection that seems worse that what would be expected. The size of the reaction area is 6 inches up and down by 5 inches around my arm. Even today, 3 days later, the discomfort and swelling still exists. I am also concerned about whether the shot is still effective or if I now have to get another shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: Extreme chills, 102.4 fever, body aches, headache, swelling and soreness at injection site. After 34 hours symptoms diminished and was left with body weakness, soreness and swelling at  injection site and slight headache.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme chills, 102.4 fever, body aches, headache, swelling and soreness at injection site. After 34 hours symptoms diminished and was left with body weakness, soreness and swelling at  injection site and slight headache.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Head discomfort, Myalgia, Poor quality sleep
Clinical narrative: I had the injection late morning. Beginning in the afternoon I became progressively more tired, with generalized muscle soreness into the evening. I went to bed very tired with muscle soreness and even a pressure deep in the mid-line of my head. I had a fretful nights sleep, but felt some better in the morning with some tiredness and muscle soreness remaining. I would add the I'm in good physical condition. I run 5 miles four days a week and lift wights for an hour or more three days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersomnia, Impaired driving ability, Impaired work ability, Injection site pain
Clinical narrative: I had soreness and rash at/near injection site but major side effect for 2nd shingles shot was sleepiness on Sunday. However, I had chills and trouble sleeping Saturday night. Very restless. I went to bed at 3 pm Sunday 12/30/2018 and could not wake up until 6:30 a.m. to use bathroom, back to bed and was able to get up at 8 a.m. Total of 17 hours sleep. Had to call off of work 12/31/2018 Monday a.m. as I was afraid to try to drive as was still dozing off.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Insomnia, Restlessness, Somnolence
Clinical narrative: I had soreness and rash at/near injection site but major side effect for 2nd shingles shot was sleepiness on Sunday. However, I had chills and trouble sleeping Saturday night. Very restless. I went to bed at 3 pm Sunday 12/30/2018 and could not wake up until 6:30 a.m. to use bathroom, back to bed and was able to get up at 8 a.m. Total of 17 hours sleep. Had to call off of work 12/31/2018 Monday a.m. as I was afraid to try to drive as was still dozing off.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Woke up in the am very achy, stiff neck, headache. Relieved with pain reliever.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Exercise tolerance decreased, Fatigue, Headache, Myalgia
Clinical narrative: Member felt fatigue, muscle aches, joint pain, headaches, itching, and decreased exercise tolerance the morning following her first administration of Anthrax. Itching resolved after one month's time, however, after second dose all other symptoms are still present and have worsened in intensity. Member is currently being worked up at Clinic for this issue and has immunologist appointment scheduled 09JAN19 for further lab work and evaluation. Treatment so far has been supportive as well as OTC herbal remedies including essential oils (Frankincense) with minimal improvement.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: Member felt fatigue, muscle aches, joint pain, headaches, itching, and decreased exercise tolerance the morning following her first administration of Anthrax. Itching resolved after one month's time, however, after second dose all other symptoms are still present and have worsened in intensity. Member is currently being worked up at Clinic for this issue and has immunologist appointment scheduled 09JAN19 for further lab work and evaluation. Treatment so far has been supportive as well as OTC herbal remedies including essential oils (Frankincense) with minimal improvement.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Fatigue, Gait disturbance, Hypotension, Nodule
Clinical narrative: Pt called Saturday 1/5 stating that he felt that he had an adverse reaction to the flu shot. He stated that he felt tired, lower blood pressure, difficulty standing/walking on his own (stated that he had to use his walker more frequently), and reported nodules/knots in his leg. When asked, he did NOT report fever, swelling, SOB, rashes, pain, or soreness.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: Pt called Saturday 1/5 stating that he felt that he had an adverse reaction to the flu shot. He stated that he felt tired, lower blood pressure, difficulty standing/walking on his own (stated that he had to use his walker more frequently), and reported nodules/knots in his leg. When asked, he did NOT report fever, swelling, SOB, rashes, pain, or soreness.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: Pt was given SHINGRIX, Developed red/inflamed area on arm slightly below (1 inch) injection sight which grew in size, went to MD and diagnosed as cellulitis. Pt seems to be improving with oral cephalexin treatment.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal pain, Pyrexia
Clinical narrative: Shoulder pain, headache, fever, fatigue.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Hyperaesthesia, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: By mid-afternoon intense ache spreading down upper arm; becoming uncomfortable and difficult to raise arm. By evening upper arm severely ached and beginning to swell; felt arm, and I could not raise my arm up to my mouth. Also skin of upper arm extremely sensitive to touch. Sleeping was difficult due to pain and touch sensitivity; do not believe I had a fever. Following day pain and inability to comfortably move arm increased significantly; waves of intense pain would ebb and flow most of the day and into the night. By third day these symptoms began to subside in frequency and intensity and did so gradually over the following 5-6 days. By Day 8 or 9 most symptoms were gone with only very occasional episode of localized itching and minimal swelling. On Day 10 only remaining symptom was an occasional localized itching in the underarm, especially in the morning which resolved in the next day or two. Have had no symptoms or ill effects since that time.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Swelling
Clinical narrative: By mid-afternoon intense ache spreading down upper arm; becoming uncomfortable and difficult to raise arm. By evening upper arm severely ached and beginning to swell; felt arm, and I could not raise my arm up to my mouth. Also skin of upper arm extremely sensitive to touch. Sleeping was difficult due to pain and touch sensitivity; do not believe I had a fever. Following day pain and inability to comfortably move arm increased significantly; waves of intense pain would ebb and flow most of the day and into the night. By third day these symptoms began to subside in frequency and intensity and did so gradually over the following 5-6 days. By Day 8 or 9 most symptoms were gone with only very occasional episode of localized itching and minimal swelling. On Day 10 only remaining symptom was an occasional localized itching in the underarm, especially in the morning which resolved in the next day or two. Have had no symptoms or ill effects since that time.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Gastrooesophageal reflux disease, Rash, Swelling
Clinical narrative: Both doses of SHIINGRIX were administered. Until second reaction, was having symptoms but did not know I was having a reaction to the vaccine. NOTE Was new walk-in patient at Clinic. Health care provider was notified of allergy to pork and porcine products. There doesn't seem to be a place for providers to store information about something that sounds like a food allergy, nor did he find a warning on SHINGRIX like the egg warning on flu vaccines. This would be helpful. Adverse reaction to Armour Thyroid in 2005-2006. Caused severe edema in feet and ankles. Since then, ingestion (eating) of any pork product may cause GI discomfort, diarrhea, rash/hives along inner arms, swelling. I tell every medical provider that I am allergic to pork and porcine products. I usually give Armour Thyroid as an example. Reaction to first vaccine was extreme reflux, which started 7-10 days post injection and lasted 2 to 2 1/2 months. I have reflux that is well controlled with daily a.m. dose of 10 mg of omeprazole. During this time, reflux returned daily around 6pm and often could not be controlled despite additional meds and significant alteration to diet. It finally began to resolve around late November. Reaction to second injection was edema in feet and ankles. Injection was administered 12/07/18. Edema was pronounced by 12/15/18. After routine endocrine visit on 12/18/18 (at which she said I was carrying 5-10 lbs of fluid), I looked up "ingredients" in SHINGRIX and found "hydrolyzed porcine gelatin." Swelling finally began to resolve 1/4/19. BP was elevated from September through end December. No treatment was sought. Reaction resolved on its own.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Both doses of SHIINGRIX were administered. Until second reaction, was having symptoms but did not know I was having a reaction to the vaccine. NOTE Was new walk-in patient at Clinic. Health care provider was notified of allergy to pork and porcine products. There doesn't seem to be a place for providers to store information about something that sounds like a food allergy, nor did he find a warning on SHINGRIX like the egg warning on flu vaccines. This would be helpful. Adverse reaction to Armour Thyroid in 2005-2006. Caused severe edema in feet and ankles. Since then, ingestion (eating) of any pork product may cause GI discomfort, diarrhea, rash/hives along inner arms, swelling. I tell every medical provider that I am allergic to pork and porcine products. I usually give Armour Thyroid as an example. Reaction to first vaccine was extreme reflux, which started 7-10 days post injection and lasted 2 to 2 1/2 months. I have reflux that is well controlled with daily a.m. dose of 10 mg of omeprazole. During this time, reflux returned daily around 6pm and often could not be controlled despite additional meds and significant alteration to diet. It finally began to resolve around late November. Reaction to second injection was edema in feet and ankles. Injection was administered 12/07/18. Edema was pronounced by 12/15/18. After routine endocrine visit on 12/18/18 (at which she said I was carrying 5-10 lbs of fluid), I looked up "ingredients" in SHINGRIX and found "hydrolyzed porcine gelatin." Swelling finally began to resolve 1/4/19. BP was elevated from September through end December. No treatment was sought. Reaction resolved on its own.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary nerve injury, Injection site pain, Pain, Pain in extremity, Peripheral nerve palsy
Clinical narrative: Intense burning pain during administration, radiated all the way down the arm. Shooting, throbbing pain with movement lasting 3 months. Diagnosed with axillary nerve damage/ palsy
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: The second arm was very sore and then the body ached severely for about 24 hours.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Pyrexia, Tremor
Clinical narrative: Very severe shaking throughout all muscles of body. Lasted about 2 hours from onset at 10 pm on day of injection and then slowly subsided. Could not sleep for the rest of the night. Feverish on second night and rather tired next day.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Malaise
Clinical narrative: All over pain, chills, temperature, sweating, headache, just felt sick all over all night. Next day I am some better but still have chill, muscle pain, and feel sick all over.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: All over pain, chills, temperature, sweating, headache, just felt sick all over all night. Next day I am some better but still have chill, muscle pain, and feel sick all over.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Confusional state, Headache, Mental impairment, Myalgia
Clinical narrative: So every vaccine I have ever had in my life I have gotten reactions from within the hr of getting them. With in the last 5 years I got the DTAP AND TDAP and the CDC said I was having Severe reactions and to see the ER. This year I got my flu shot in Oct, and again I had reactions. My reactions always start with in the hr of getting them. Yesterday I got the pneumonia vaccine, and a hr later I got body rashes, I was itchy, confused, skin on my body felt like it was on fire and burning all over my body... hard to think, ect. Dr said I was having mild vaccine reactions to the shot, and to report it here. Well today my brain still hurts, still have body itching and skin on entire body feels like it is badly burned, and I am still rashy but nothing like I was yesterday, muscles hurt badly still, and more. What do I do? Dr's say there isn't much they can do for me. These vaccine reactions are effecting my mood and my life right now. What do I do to rid these vaccine reactions? The skin itching and burning is currently the worst symptoms as of right now.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash generalised, Vaccination complication
Clinical narrative: So every vaccine I have ever had in my life I have gotten reactions from within the hr of getting them. With in the last 5 years I got the DTAP AND TDAP and the CDC said I was having Severe reactions and to see the ER. This year I got my flu shot in Oct, and again I had reactions. My reactions always start with in the hr of getting them. Yesterday I got the pneumonia vaccine, and a hr later I got body rashes, I was itchy, confused, skin on my body felt like it was on fire and burning all over my body... hard to think, ect. Dr said I was having mild vaccine reactions to the shot, and to report it here. Well today my brain still hurts, still have body itching and skin on entire body feels like it is badly burned, and I am still rashy but nothing like I was yesterday, muscles hurt badly still, and more. What do I do? Dr's say there isn't much they can do for me. These vaccine reactions are effecting my mood and my life right now. What do I do to rid these vaccine reactions? The skin itching and burning is currently the worst symptoms as of right now.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising
Clinical narrative: Pt presented with a bruise at the injection site and other bruises further down her arm and leg on the left side of her body. She stated they did not hurt but appeared after she recieved the 2nd dose of the shingles vaccine.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Cyanosis, Febrile convulsion, Hypotonia, Influenza virus test, Pyrexia
Clinical narrative: At 4:30 am she stopped breathing and turned blue and went limp. They said she had a febrile seizure. She woke up and was awake at 4am and all of a sudden it happened out of no where.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Respiratory arrest
Clinical narrative: At 4:30 am she stopped breathing and turned blue and went limp. They said she had a febrile seizure. She woke up and was awake at 4am and all of a sudden it happened out of no where.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient came in the following day after vaccination with swelling in the upper arm and area was hot to the touch on the arm that was injected. She also reported a lot of pain in the arm of injection.
Age: 28.0
Sex: M
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Rash erythematous, Swelling
Clinical narrative: Red localized rash and swelling.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash macular
Clinical narrative: Arm is swollen, red blotches along the bicep and tricep areas. Blotches are also under the arm and up the chest. Patient also reports red circles.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Cough, Headache, Injection site erythema, Injection site induration
Clinical narrative: Fever that lasted from Thursday 1/03 through early morning on Saturday 1/05. Extremely sore upper left arm that became red and hot to the touch. That pain travelled partially down the arm and also along the inner left side of the body (below armpit). Large red welt at site where shot was given--large and round like a baseball, hot and hard to the touch on Saturday...must have been worse on Friday but I was too sick to look at it--it never occurred to me that I could see it. Achy head, back aches, coughing, stiffness (stiff neck).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Fever that lasted from Thursday 1/03 through early morning on Saturday 1/05. Extremely sore upper left arm that became red and hot to the touch. That pain travelled partially down the arm and also along the inner left side of the body (below armpit). Large red welt at site where shot was given--large and round like a baseball, hot and hard to the touch on Saturday...must have been worse on Friday but I was too sick to look at it--it never occurred to me that I could see it. Achy head, back aches, coughing, stiffness (stiff neck).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever that lasted from Thursday 1/03 through early morning on Saturday 1/05. Extremely sore upper left arm that became red and hot to the touch. That pain travelled partially down the arm and also along the inner left side of the body (below armpit). Large red welt at site where shot was given--large and round like a baseball, hot and hard to the touch on Saturday...must have been worse on Friday but I was too sick to look at it--it never occurred to me that I could see it. Achy head, back aches, coughing, stiffness (stiff neck).
Age: 19.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Loss of consciousness
Clinical narrative: Patient came into the pharmacy and wanted group B meningococcal vaccine (TRUMENBA). This was given without incident. An hour or two later when she got home she called the pharmacy indicating she had passed out. I advised her to go to the emergency room. I called a few minutes later and she indicated that she was feeling much better and was getting something to eat.
Age: 73.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Severe chills, shivering, fever, headache, nausea.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Pain, Pyrexia
Clinical narrative: Pt experience severe back pain, body ache, fever, and injection site pain. He stated this didn't happen with the 1st dose of SHINGRIX. He hadn't been able to get out of the bed the day of the second shot. And took some APAP, which did bring down the fever.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site nodule, Injection site rash, Rash
Clinical narrative: Large knot developed on arm at injection site. Rash appeared at site and radiated down arm.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Hyperaesthesia, Pain, Pruritus, Rash
Clinical narrative: Fatigue, pain, development of itchy sores on right side of body and back. Sensitivity in the breast to clothing in armpit area, itching in that same area and small punctate bumps on the breast. Itching on backs of legs, upper arms and back. Hair follicle density seems to have decreased as well.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: About 5 hours after I got the SHINGRIX shot, I started getting chills and also had a low grade fever. Later that night I had one of the worst headaches of my life and also became quite nauseous.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Influenza like illness, Injection site erythema, Injection site pain, Migraine
Clinical narrative: Flu like symptons (no Nausea), pain, redness, below the injection site on arm, pain in joint of great toe, incipient migraine. Probably started night of Jan 4, bed rest/sleeping all of Jan 5, mostly resolved except for arm pain/redness (area approx 4" by 3") upon waking Jan 6.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Flu like symptons (no Nausea), pain, redness, below the injection site on arm, pain in joint of great toe, incipient migraine. Probably started night of Jan 4, bed rest/sleeping all of Jan 5, mostly resolved except for arm pain/redness (area approx 4" by 3") upon waking Jan 6.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Patient repoted swelling around the injection site and arm pain which started 2-3 days after the vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Sore arm at injection site. Muscle ache, headache, chills. Started approximately twelve hours post injection. It's now 11:30am and feeling somewhat better (no chills although other symptoms persist to lesser extent). Had similar but more severe symptoms after first dose administered in Oct, 2018.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Pruritus, Rash, Urticaria
Clinical narrative: Began with mild itching under left and right armpits and itching along groin area. Itching at scalp, neck, under armpits, under chin, stomach area, inside thighs, groin area. Hives under armpits and in groin (bikini line) spreading to inner thighs and underside of arms. Symptoms prevalent throughout the day but itching increases in the evening and during sleep. Hives are red, inflamed, appear as tiny dots. I've been keeping the area clean and dry. I will see my doctor next week.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain in extremity
Clinical narrative: Patient said that the night of the vaccination she experienced some discomfort and pain at the injection site, then the following day the pain continued but the arm was still functional, the following day her arm was very painful and sore and she could barely move her arm. I advised her to see urgent care and let her PCP know. In the meantime she can use some ibuprofen and ice the arm.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: Severe headache and flu like symptoms. Talked to him today (1-6-19) and he said he was much better.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Musculoskeletal pain, Neck pain, Neuropathy peripheral, Pain in extremity
Clinical narrative: After 2nd shot, extreme arm pain. Numbness, pins and needles, nerve issues, in shoulder, down arm, and into hand. Severe pain in neck and shoulder. Symptoms have been non stop, and worse now that even at beginning.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: After 2nd shot, extreme arm pain. Numbness, pins and needles, nerve issues, in shoulder, down arm, and into hand. Severe pain in neck and shoulder. Symptoms have been non stop, and worse now that even at beginning.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: After 2nd shot, extreme arm pain. Numbness, pins and needles, nerve issues, in shoulder, down arm, and into hand. Severe pain in neck and shoulder. Symptoms have been non stop, and worse now that even at beginning.