chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Biopsy skin abnormal, Micrographic skin surgery, Skin lesion, Squamous cell carcinoma of skin
Clinical narrative: 3 lesions on lower left leg--non-healing.  Seen in Urgent Care 3/13/23.  Referred to Dermatologist for biopsy.  Results of biopsies:  Invasive Squamous Cell Carcinoma, well differentiated with Keratoacanthoma-like features  Mohs surgery performed on 2 lesions on 4/10/2023 Cauterization done on 3rd lesion on 7/19/2023
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: An expired dose of MMRV (Proquad) administered to patient.  Dose expired 4/6/23.    Contacted CDC and Merck for guidance.  Per CDC and Merck, no expectation of patient harm.   Dose potency potentially diminished.   Consider additional booster at least 4 weeks after administration date.  Log dose as invalid.  Administering medical professional attempting to contact patient parent to advise and schedule appointment  to reimmunize with additional booster of MMRV after 4 weeks.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Bone pain, C-reactive protein increased, Erythema, Full blood count abnormal
Clinical narrative: Extreme swelling at injection site the size of a golf ball under the skin. Red painful arm. Severe pain when trying to love arm. Bones , joints and muscle pain worsening each day. Entire body inflamed. Treatment started day 6 as symptoms worsened.. Treatment started 40 mg of prednisone.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Inflammation, Injection site swelling, Myalgia, Neutrophil count increased, Pain
Clinical narrative: Extreme swelling at injection site the size of a golf ball under the skin. Red painful arm. Severe pain when trying to love arm. Bones , joints and muscle pain worsening each day. Entire body inflamed. Treatment started day 6 as symptoms worsened.. Treatment started 40 mg of prednisone.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Extreme swelling at injection site the size of a golf ball under the skin. Red painful arm. Severe pain when trying to love arm. Bones , joints and muscle pain worsening each day. Entire body inflamed. Treatment started day 6 as symptoms worsened.. Treatment started 40 mg of prednisone.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Blood glucose abnormal, Diabetes mellitus, Full blood count, Glycosylated haemoglobin
Clinical narrative: 1) thrombocytopenia (platelet count of 3k) diagnosed 7/24/2021 after complaint of spontaneous bruising. consulted hematology, treated with 2 short courses of dexamethasone, resolved. (this incident may have already been reported by the hematologist). 2) autoimmune (type 1 or "1.5") diabetes diagnosed 7/27/2023 (positive GAD65 antibody). blood sugar first became abnormal in 9/2021, but has increased dramatically from 10/2022 to present, despite excellent diet and use of semaglutide. there has been no major illness in the past 2 years so based on the timeline it appears that T1D may be an adverse effect of this vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Increased tendency to bruise, Platelet count decreased, Thrombocytopenia
Clinical narrative: 1) thrombocytopenia (platelet count of 3k) diagnosed 7/24/2021 after complaint of spontaneous bruising. consulted hematology, treated with 2 short courses of dexamethasone, resolved. (this incident may have already been reported by the hematologist). 2) autoimmune (type 1 or "1.5") diabetes diagnosed 7/27/2023 (positive GAD65 antibody). blood sugar first became abnormal in 9/2021, but has increased dramatically from 10/2022 to present, despite excellent diet and use of semaglutide. there has been no major illness in the past 2 years so based on the timeline it appears that T1D may be an adverse effect of this vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Balance disorder, Dizziness, Epstein-Barr virus infection, Headache
Clinical narrative: Strong cold and flu-type symptoms first 3 weeks. Right Thyroid pain and asthma, wheezing. Evolved to dizziness, equilibrium issues, sensitivity to light and sound, and headaches until October, when I could be seen and assessed by a neurologist who determined post-vaccine vertigo and equilibrium issues. I now have chronic viral persistence (EBV for sure and cold sore), and neurological issues that come and go. Numbness, tingling in face and hands, blurred vision, light and sound sensitivity, equilibrium issues and gravitational pulls, muscle weakness, post-exertional malaise, and extremely weak immune system. Inability to function like normal without becoming sick.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Hypoaesthesia, Illness, Immune system disorder, Influenza
Clinical narrative: Strong cold and flu-type symptoms first 3 weeks. Right Thyroid pain and asthma, wheezing. Evolved to dizziness, equilibrium issues, sensitivity to light and sound, and headaches until October, when I could be seen and assessed by a neurologist who determined post-vaccine vertigo and equilibrium issues. I now have chronic viral persistence (EBV for sure and cold sore), and neurological issues that come and go. Numbness, tingling in face and hands, blurred vision, light and sound sensitivity, equilibrium issues and gravitational pulls, muscle weakness, post-exertional malaise, and extremely weak immune system. Inability to function like normal without becoming sick.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Muscular weakness, Nasopharyngitis, Neurological examination abnormal
Clinical narrative: Strong cold and flu-type symptoms first 3 weeks. Right Thyroid pain and asthma, wheezing. Evolved to dizziness, equilibrium issues, sensitivity to light and sound, and headaches until October, when I could be seen and assessed by a neurologist who determined post-vaccine vertigo and equilibrium issues. I now have chronic viral persistence (EBV for sure and cold sore), and neurological issues that come and go. Numbness, tingling in face and hands, blurred vision, light and sound sensitivity, equilibrium issues and gravitational pulls, muscle weakness, post-exertional malaise, and extremely weak immune system. Inability to function like normal without becoming sick.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Oral herpes, Paraesthesia, Photophobia, Thyroid pain
Clinical narrative: Strong cold and flu-type symptoms first 3 weeks. Right Thyroid pain and asthma, wheezing. Evolved to dizziness, equilibrium issues, sensitivity to light and sound, and headaches until October, when I could be seen and assessed by a neurologist who determined post-vaccine vertigo and equilibrium issues. I now have chronic viral persistence (EBV for sure and cold sore), and neurological issues that come and go. Numbness, tingling in face and hands, blurred vision, light and sound sensitivity, equilibrium issues and gravitational pulls, muscle weakness, post-exertional malaise, and extremely weak immune system. Inability to function like normal without becoming sick.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vision blurred, Wheezing
Clinical narrative: Strong cold and flu-type symptoms first 3 weeks. Right Thyroid pain and asthma, wheezing. Evolved to dizziness, equilibrium issues, sensitivity to light and sound, and headaches until October, when I could be seen and assessed by a neurologist who determined post-vaccine vertigo and equilibrium issues. I now have chronic viral persistence (EBV for sure and cold sore), and neurological issues that come and go. Numbness, tingling in face and hands, blurred vision, light and sound sensitivity, equilibrium issues and gravitational pulls, muscle weakness, post-exertional malaise, and extremely weak immune system. Inability to function like normal without becoming sick.
Age: 19.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Skin warm
Clinical narrative: localized reaction including surrounding redness/warmth with central induration persisting at least one week following vaccine
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediarix was administered inadvertently instead of Kinrix for final DTap and IPV in series. Mom reports child doing well; no adverse side effects.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Fall, Fear of injection, Head injury, Headache
Clinical narrative: The patient told me he had an acute fear of needles and vaccines. He was very nervous and shaking. He was seated, I told him to look at his mom and concentrate on her face. I administered the vaccine around 1.09pm while telling him he's doing a good job. He appeared normal afterwards, and he and his mom proceeded to walk down the corridor in front the pharmacy. He told his mom about a minute after  that he felt faint, and fell on her shoulder, then unto the ground. He hit his head. He fainted. He was conscious a couple seconds after and talking normally. I gave him a bottle of water and orange juice, which he drank. He did not eat breakfast that morning and was leaving for college in 2 days and felt overwhelmed. His head was sore from the fall. He said he felt fine after 10 minutes. He left the store on a powered cart to go home.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Nervousness, Syncope, Tremor
Clinical narrative: The patient told me he had an acute fear of needles and vaccines. He was very nervous and shaking. He was seated, I told him to look at his mom and concentrate on her face. I administered the vaccine around 1.09pm while telling him he's doing a good job. He appeared normal afterwards, and he and his mom proceeded to walk down the corridor in front the pharmacy. He told his mom about a minute after  that he felt faint, and fell on her shoulder, then unto the ground. He hit his head. He fainted. He was conscious a couple seconds after and talking normally. I gave him a bottle of water and orange juice, which he drank. He did not eat breakfast that morning and was leaving for college in 2 days and felt overwhelmed. His head was sore from the fall. He said he felt fine after 10 minutes. He left the store on a powered cart to go home.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported to facility, however patient given Engerix-B indicated for 20 years old and older but patient 17 years old at time of vaccination
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia
Clinical narrative: Patient started experiencing heart rhythm irregularities in July.  She was seen by a doctor and prescribed medications. She believes this to be related to her shingles shot on May 30,2023.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Eye pain, Headache, Heart rate increased
Clinical narrative: Four hours post vaccine: muscle/joint pain, low grade fever, extreme soreness at injection site.  Overnight: Fever, extreme muscle/joint pain (unable to sleep due to pain), eye pain 2 and 3 days post vaccine: Muscle / joint pain, extreme eye pain, extreme headache (not helped by Tylenol), fever, vomiting, extreme nausea, unable to continue daily activities (spent most of the day in bed), elevated heart rate, chest pain (improved when lying down)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Myalgia, Nausea, Pyrexia
Clinical narrative: Four hours post vaccine: muscle/joint pain, low grade fever, extreme soreness at injection site.  Overnight: Fever, extreme muscle/joint pain (unable to sleep due to pain), eye pain 2 and 3 days post vaccine: Muscle / joint pain, extreme eye pain, extreme headache (not helped by Tylenol), fever, vomiting, extreme nausea, unable to continue daily activities (spent most of the day in bed), elevated heart rate, chest pain (improved when lying down)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Vomiting
Clinical narrative: Four hours post vaccine: muscle/joint pain, low grade fever, extreme soreness at injection site.  Overnight: Fever, extreme muscle/joint pain (unable to sleep due to pain), eye pain 2 and 3 days post vaccine: Muscle / joint pain, extreme eye pain, extreme headache (not helped by Tylenol), fever, vomiting, extreme nausea, unable to continue daily activities (spent most of the day in bed), elevated heart rate, chest pain (improved when lying down)
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Swelling, Urticaria
Clinical narrative: Local swelling at injection site, per mother's report had bluish hue 3 days after injection then red, hive like  now red flat confluent area with satelite redness
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Arthroscopic surgery, Injected limb mobility decreased, Injection site inflammation, Joint debridement, Magnetic resonance imaging
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm and shoulder (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe and debilitating, were somewhat alleviated with ongoing PT regimen. After 15 months(!) with little to no improvement, it was suggested by this patient's very kind, but frustrated, doctor, that surgical intervention was needed. An extensive arthroscopic procedure with debridement and manipulation  was performed; recovery took another 9 weeks, but ultimately pain & mobility issues improved. **Of note:A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, and felt exactly like the problems that had shown up in the left arm, but were much less severe and only lasted 2-3months. We were told that this phenomenon is called SIRVA - Shoulder Injury Relative to Vaccine Administration -and that it's very real. One explanation is that some of these injections are given too high in the arm, above the intended deltoid muscle target and injected into the shoulder capsule; then, for some reason, the injected vaccine triggers an immune mediated inflammatory response in the shoulder capsule, perhaps...? No one has been able to put forth a definitive answer. Can vaccine diluents trigger some kind of allergic reaction in some people?... I experienced the same symptoms with both Covid and Flu vaccines.  I have now completely recovered from that painful, debilitating experience, but NEVER want to go through it again. I will NEVER opt for intramuscular vaccination in either of my arms. My husband (a retired physician) and I are VERY much in favor of vaccines, And Science. I am absolutely NOT seeking monetary compensation. I am simply asking for advice - alternative methods of vaccination that might be available to me, should the need arise. Nasal spray? Hip/thigh injection sites...?although that seems a bit risky, as it's still intramuscular? Smaller doses given intermittently..? Has ANYONE researched anything like this at all? I would  greatly appreciate any help you could give me in this matter.  I previously wrote an extensive history of the entire ordeal, with personal information and background, and will try to forward a copy of it to this site.    PLEASE EMAIL ME YOUR HELPFUL THOUGHTS ON THE ABOVE QUESTIONS AND CONCERNS. Thank you so much!!
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Mobility decreased, Pain, Pain in extremity, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm and shoulder (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe and debilitating, were somewhat alleviated with ongoing PT regimen. After 15 months(!) with little to no improvement, it was suggested by this patient's very kind, but frustrated, doctor, that surgical intervention was needed. An extensive arthroscopic procedure with debridement and manipulation  was performed; recovery took another 9 weeks, but ultimately pain & mobility issues improved. **Of note:A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, and felt exactly like the problems that had shown up in the left arm, but were much less severe and only lasted 2-3months. We were told that this phenomenon is called SIRVA - Shoulder Injury Relative to Vaccine Administration -and that it's very real. One explanation is that some of these injections are given too high in the arm, above the intended deltoid muscle target and injected into the shoulder capsule; then, for some reason, the injected vaccine triggers an immune mediated inflammatory response in the shoulder capsule, perhaps...? No one has been able to put forth a definitive answer. Can vaccine diluents trigger some kind of allergic reaction in some people?... I experienced the same symptoms with both Covid and Flu vaccines.  I have now completely recovered from that painful, debilitating experience, but NEVER want to go through it again. I will NEVER opt for intramuscular vaccination in either of my arms. My husband (a retired physician) and I are VERY much in favor of vaccines, And Science. I am absolutely NOT seeking monetary compensation. I am simply asking for advice - alternative methods of vaccination that might be available to me, should the need arise. Nasal spray? Hip/thigh injection sites...?although that seems a bit risky, as it's still intramuscular? Smaller doses given intermittently..? Has ANYONE researched anything like this at all? I would  greatly appreciate any help you could give me in this matter.  I previously wrote an extensive history of the entire ordeal, with personal information and background, and will try to forward a copy of it to this site.    PLEASE EMAIL ME YOUR HELPFUL THOUGHTS ON THE ABOVE QUESTIONS AND CONCERNS. Thank you so much!!
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Arthroscopic surgery, Asthenia, Debridement, Frustration tolerance decreased, Injected limb mobility decreased
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm and shoulder (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe and debilitating, were somewhat alleviated with ongoing PT regimen. After 15 months(!) with little to no improvement, it was suggested by this patient's very kind, but frustrated, doctor, that surgical intervention was needed. An extensive arthroscopic procedure with debridement and manipulation  was performed; recovery took another 9 weeks, but ultimately pain & mobility issues improved. **Of note:A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, and felt exactly like the problems that had shown up in the left arm, but were much less severe and only lasted 2-3months. We were told that this phenomenon is called SIRVA - Shoulder Injury Relative to Vaccine Administration -and that it's very real. One explanation is that some of these injections are given too high in the arm, above the intended deltoid muscle target and injected into the shoulder capsule; then, for some reason, the injected vaccine triggers an immune mediated inflammatory response in the shoulder capsule, perhaps...? No one has been able to put forth a definitive answer. Can vaccine diluents trigger some kind of allergic reaction in some people?... I experienced the same symptoms with both Covid and Flu vaccines.  I have now completely recovered from that painful, debilitating experience, but NEVER want to go through it again. I will NEVER opt for intramuscular vaccination in either of my arms. My husband (a retired physician) and I are VERY much in favor of vaccines, And Science. I am absolutely NOT seeking monetary compensation. I am simply asking for advice - alternative methods of vaccination that might be available to me, should the need arise. Nasal spray? Hip/thigh injection sites...?although that seems a bit risky, as it's still intramuscular? Smaller doses given intermittently..? Has ANYONE researched anything like this at all? I would  greatly appreciate any help you could give me in this matter.  I previously wrote an extensive history of the entire ordeal, with personal information and background, and will try to forward a copy of it to this site.    PLEASE EMAIL ME YOUR HELPFUL THOUGHTS ON THE ABOVE QUESTIONS AND CONCERNS. Thank you so much!!
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Injection site inflammation, Injection site pain, Magnetic resonance imaging, Manipulation, Pain in extremity
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm and shoulder (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe and debilitating, were somewhat alleviated with ongoing PT regimen. After 15 months(!) with little to no improvement, it was suggested by this patient's very kind, but frustrated, doctor, that surgical intervention was needed. An extensive arthroscopic procedure with debridement and manipulation  was performed; recovery took another 9 weeks, but ultimately pain & mobility issues improved. **Of note:A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, and felt exactly like the problems that had shown up in the left arm, but were much less severe and only lasted 2-3months. We were told that this phenomenon is called SIRVA - Shoulder Injury Relative to Vaccine Administration -and that it's very real. One explanation is that some of these injections are given too high in the arm, above the intended deltoid muscle target and injected into the shoulder capsule; then, for some reason, the injected vaccine triggers an immune mediated inflammatory response in the shoulder capsule, perhaps...? No one has been able to put forth a definitive answer. Can vaccine diluents trigger some kind of allergic reaction in some people?... I experienced the same symptoms with both Covid and Flu vaccines.  I have now completely recovered from that painful, debilitating experience, but NEVER want to go through it again. I will NEVER opt for intramuscular vaccination in either of my arms. My husband (a retired physician) and I are VERY much in favor of vaccines, And Science. I am absolutely NOT seeking monetary compensation. I am simply asking for advice - alternative methods of vaccination that might be available to me, should the need arise. Nasal spray? Hip/thigh injection sites...?although that seems a bit risky, as it's still intramuscular? Smaller doses given intermittently..? Has ANYONE researched anything like this at all? I would  greatly appreciate any help you could give me in this matter.  I previously wrote an extensive history of the entire ordeal, with personal information and background, and will try to forward a copy of it to this site.    PLEASE EMAIL ME YOUR HELPFUL THOUGHTS ON THE ABOVE QUESTIONS AND CONCERNS. Thank you so much!!
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Shoulder injury related to vaccine administration, X-ray
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm and shoulder (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe and debilitating, were somewhat alleviated with ongoing PT regimen. After 15 months(!) with little to no improvement, it was suggested by this patient's very kind, but frustrated, doctor, that surgical intervention was needed. An extensive arthroscopic procedure with debridement and manipulation  was performed; recovery took another 9 weeks, but ultimately pain & mobility issues improved. **Of note:A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, and felt exactly like the problems that had shown up in the left arm, but were much less severe and only lasted 2-3months. We were told that this phenomenon is called SIRVA - Shoulder Injury Relative to Vaccine Administration -and that it's very real. One explanation is that some of these injections are given too high in the arm, above the intended deltoid muscle target and injected into the shoulder capsule; then, for some reason, the injected vaccine triggers an immune mediated inflammatory response in the shoulder capsule, perhaps...? No one has been able to put forth a definitive answer. Can vaccine diluents trigger some kind of allergic reaction in some people?... I experienced the same symptoms with both Covid and Flu vaccines.  I have now completely recovered from that painful, debilitating experience, but NEVER want to go through it again. I will NEVER opt for intramuscular vaccination in either of my arms. My husband (a retired physician) and I are VERY much in favor of vaccines, And Science. I am absolutely NOT seeking monetary compensation. I am simply asking for advice - alternative methods of vaccination that might be available to me, should the need arise. Nasal spray? Hip/thigh injection sites...?although that seems a bit risky, as it's still intramuscular? Smaller doses given intermittently..? Has ANYONE researched anything like this at all? I would  greatly appreciate any help you could give me in this matter.  I previously wrote an extensive history of the entire ordeal, with personal information and background, and will try to forward a copy of it to this site.    PLEASE EMAIL ME YOUR HELPFUL THOUGHTS ON THE ABOVE QUESTIONS AND CONCERNS. Thank you so much!!
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Blood creatine phosphokinase, C-reactive protein increased, Erythema, Full blood count
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lymphadenopathy, Malaise, Metabolic function test, Muscular weakness, Myalgia
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urine analysis, Urticaria
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy skin, Biopsy skin abnormal, Brain fog, Deformity, Erythema
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Flushing, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased, Muscular weakness
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nail bed inflammation, Pain, Pain of skin, Pruritus, Pyrexia
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scar, Scratch, Skin lesion, Skin swelling, Skin tightness
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling, Swelling face, Urticaria, Wound
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aphthous ulcer, Brain fog, Fall, Fatigue, Injection site erythema
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site vesicles, Lymphadenopathy
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness, Pain, Pruritus, Pyrexia
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Within one day of receiving shingrix vaccine, the injection site began to turn deep red, hard, hot to touch, and painful to slightest touch and the size of a fist. April 8 began 1st of 4 weekly .25 mg doses of Ozempic. discontinued after 4th dose. Antibiotics prescribed April 24 when Dr observed deeply inflamed, swollen, hot to touch, size of fist injection site.; itching on arms started followed by goosebump size, hive like raised skin that did not remain long. May 1 - 7th fever, slept 15 hours a day, began to loose muscle strength in arms and legs resulting in loss of mobility, foggy brained, pock-like sores began to appear in the areas that were scratched in response to all over itchy-ness.   May 8 Dr
Age: 0.17
Sex: F
Vaccine: RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from nurseand refers to a 2-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 26-JUN-2023, the patient started therapy with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968386, expiration date: 23-MAY-2024, administered orally (strength, and indication were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  No adverse event reported.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2307USA011227:
Age: 0.17
Sex: F
Vaccine: RV5, DTAPIPVHIB, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from nurseand refers to a 2-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 26-JUN-2023, the patient started therapy with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968386, expiration date: 23-MAY-2024, administered orally (strength, and indication were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  No adverse event reported.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2307USA011227:
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Vaccine administered into deltoid muscle. Patient stating that arm was sore next day like normal but then the soreness increased over the next couple days.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Vaccine administered into deltoid muscle. Patient stating that arm was sore next day like normal but then the soreness increased over the next couple days.
Sex: F
Vaccine: MMR
Symptoms: Contraindicated product administered
Clinical narrative: No adverse event; Pharmacist called to report that she administered MMR-II to a patient who received immunoglobulins about 2 to 3 weeks ago. Type of immunoglobulin unknown by reporter. Unknown dates of administration at time of call. Limited patient demographics and l; This spontaneous report was received from a pharmacist, concerning a non-identifiable patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On an unknown date in 2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), once, (dose, lot #, expiry date, route of administration, and anatomical location were not provided) administered for prophylaxis to a patient who had received immunoglobulins about 2 to 3 weeks ago (type of immunoglobulin was unknown by reporter) (contraindicated product administered).  No adverse event was reported.  Follow-up information was received from a pharmacist on 04-AUG-2023.The case has become valid as the pharmacist stated the patient is female.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: Caller reports that they had a temperature excursion 3/31/2023 which they called into the Facility. The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally adminis; Expired product administered; This spontaneous report was received from an office manager regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUL-2023, the patient was vaccinated with an expired and improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #W031816, expiration date: 30-JUN-2023, administered as prophylaxis (strength, and route of administration were not provided). The vaccine suffered a temperature excursion at 6 up to 14 Fahrenheit degrees for 4 hours, 14 to 46 Fahrenheit degrees for 4 hours, 47 to 77 Fahrenheit degrees for 3 hours and 57 minutes on 31-MAR-2023.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product expiration date issue, Product storage error
Clinical narrative: Caller reports that they had a temperature excursion 31-MAR-2023 for VARIVAX and was administered on 03-JUL-2023; Expiration date of 30-JUN-2023; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 31-MAR-2023, the reporter stated they had a temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) (from 6°F up to 14°F for 4 hours; from 14°F up to 46°F for 4 hours; and from 47°F to 77°F (50°F) for 3 hours and 57 minutes giving a total excursion duration of 11 hours and 57 minutes).   Later, on 03-JUL-2023, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W031816, expiration date: 30-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided). According to the reporter, the lot # involved was "short dated" and a new expiration date of 30-JUN-2023 was given (expired product administered, also reported as original expiration date was 05-OCT-2024 and confirmed upon system validation; conflicting information).  This is one of several cases received from the same reporter.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE; Improperly stored vaccine was administered after temperature excursion; This spontaneous report was received from a nurse and refers to a 17-months-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were not reported. Her historical vaccines included influenza vaccine, hepatitis B vaccine (manufacturer unknown), measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR) (manufacturer unknown), diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3V (MRC 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13), rotavirus vaccine live reassort oral 5V (ROTATEQ), and varicella vaccine (unknown manufacturer).  On 06-JUN-2023, the patient was vaccinated with Hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, administered in the left arm as prophylaxis (Lot number X003791 has been verified to be a valid lot number for vial formulation, expiration date reported as 01-JUL-2024, but upon internal validation established as 01-JUN-2024) (strength, dose, route of administration, and vaccination scheme were not reported) after temperature excursion (Product storage error). No side effects or symptoms were reported (No adverse event).  This one of several reports received from the same reporter.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no event; alarm believed to be due to sensory issues/improperly stored vaccine; This spontaneous report was received from a nurse practitioner and refers to a 02-month-old male patient. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapies included pneumococcal vaccine conj 7v (crm197)(PREVNAR), diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(PENTACEL) and hepatitis b vaccine(HEPATITIS B VACCINE).     On 06-JUN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, that was exposed to temperature excursion, lot number 1968386 with expiration 23-MAY-2024 (dose was not reported) for prophylaxis (product storage error). No event was reported.   This is one of several reports from the same source.; Sender's Comments:  US-009507513-2307USA009456: US-009507513-2306USA013096: US-009507513-2307USA009456: US-009507513-2307USA009680: US-009507513-2307USA009660: US-009507513-2307USA009636: US-009507513-2307USA010465:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional adverse event; Vaccine T029104 / 23-FEB-2022 was administered 28-FEB-2022, five days post expiry date.; This spontaneous report was received from a nurse and refers to a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 28-FEB-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) subcutaneous injection, lot #T029104 who had been verified to be a valid number and established the same expiration date: 23-FEB-2022, administered for prophylaxis (strength, dose and route of administration were not provided) (expired vaccine used). No additional adverse event.