chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine, Tooth disorder, Transferrin, Tri-iodothyronine, Troponin
Clinical narrative: I received 2 Moderna vaccines (3/25/21 and 4/27/21) with no serious side effects. I received the Pfizer booster on 12/3/21 and within 2 days developed a serious headache and stiff neck that did not go away with OTC pain relievers. I traveled home 12/11-12/12. During this time I began having severe stomach pains and was seen in the emergency room on 12/15/21. The main finding was very elevated liver enzymes. ALT and AST. Over the course of the next 6 months, I was diagnosed with autoimmune hepatitis. I also had a reactivation of EBV, VZ, Cytomegalovirus, and HSV 1. I continue to have extremely high levels of antibodies to each to. I was referred to a neurologist after developing neurological symptoms. I have been told I have a vaccine injury and this has caused autoimmune antibody-mediated small fiber neuropathy and other demyelinating occurrences. I have also developed tachycardia, digestive issues,  and dental problems. I have had CT scans, MRIs, and heart tests, including echocardiogram, blood vessel ultrasound, calcium scoring, and have an upcoming echo stress test. In addition to tachycardia, I have developed cardiovascular symptoms such as weakened blood vessels and bruising. The hepatitis has improved but resulted in a non-diet-related large increase in cholesterol. I am currently on low dose naltrexone, pregabalin, and atorvastatin, as well as a low-dose anti-anxiety medication and valcyclovir. The anxiety comes from the constant health problems and limitations and fear that I will never regain my health as it was prior to this vaccine booster. I am not an anti-vaxxer. I am a biology professor and got vaccinated because vaccines prevent disease. This vaccine, however, has markedly changed my life. I have very bad weeks, with massive inflammation and inability to carry out daily activities. I continue to have neurological symptoms including balance problems and numbness in my extremities. I have better weeks when I am hopeful I will feel well again. I have spent my savings paying for tests, imaging, and specialists. I was unable to work because of this for 8 months and am now financially struggling. I have now gone back to work part time, as I cannot afford not to. I am angry that I trusted that this vaccine was safe and beneficial to my health. I will continue to try to feel better - get the recommended medical tests and take the prescribed medications that have been given me. But, I have lost faith in both the vaccine program and the medical professionals in their ability to treat the vaccine injured. They acknowledge that I was vaccine injured, but admit that they do not know how to treat me. In fact, I have been advised by my doctors to get no vaccines at this time, which leaves me susceptible to influenza, shingles, and pneumonia. This was a health disaster for me. Thank you.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Ultrasound abdomen, Ultrasound abdomen abnormal, Ultrasound bladder, Urine analysis abnormal
Clinical narrative: I received 2 Moderna vaccines (3/25/21 and 4/27/21) with no serious side effects. I received the Pfizer booster on 12/3/21 and within 2 days developed a serious headache and stiff neck that did not go away with OTC pain relievers. I traveled home 12/11-12/12. During this time I began having severe stomach pains and was seen in the emergency room on 12/15/21. The main finding was very elevated liver enzymes. ALT and AST. Over the course of the next 6 months, I was diagnosed with autoimmune hepatitis. I also had a reactivation of EBV, VZ, Cytomegalovirus, and HSV 1. I continue to have extremely high levels of antibodies to each to. I was referred to a neurologist after developing neurological symptoms. I have been told I have a vaccine injury and this has caused autoimmune antibody-mediated small fiber neuropathy and other demyelinating occurrences. I have also developed tachycardia, digestive issues,  and dental problems. I have had CT scans, MRIs, and heart tests, including echocardiogram, blood vessel ultrasound, calcium scoring, and have an upcoming echo stress test. In addition to tachycardia, I have developed cardiovascular symptoms such as weakened blood vessels and bruising. The hepatitis has improved but resulted in a non-diet-related large increase in cholesterol. I am currently on low dose naltrexone, pregabalin, and atorvastatin, as well as a low-dose anti-anxiety medication and valcyclovir. The anxiety comes from the constant health problems and limitations and fear that I will never regain my health as it was prior to this vaccine booster. I am not an anti-vaxxer. I am a biology professor and got vaccinated because vaccines prevent disease. This vaccine, however, has markedly changed my life. I have very bad weeks, with massive inflammation and inability to carry out daily activities. I continue to have neurological symptoms including balance problems and numbness in my extremities. I have better weeks when I am hopeful I will feel well again. I have spent my savings paying for tests, imaging, and specialists. I was unable to work because of this for 8 months and am now financially struggling. I have now gone back to work part time, as I cannot afford not to. I am angry that I trusted that this vaccine was safe and beneficial to my health. I will continue to try to feel better - get the recommended medical tests and take the prescribed medications that have been given me. But, I have lost faith in both the vaccine program and the medical professionals in their ability to treat the vaccine injured. They acknowledge that I was vaccine injured, but admit that they do not know how to treat me. In fact, I have been advised by my doctors to get no vaccines at this time, which leaves me susceptible to influenza, shingles, and pneumonia. This was a health disaster for me. Thank you.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Varicella zoster virus infection, Vitamin B12
Clinical narrative: I received 2 Moderna vaccines (3/25/21 and 4/27/21) with no serious side effects. I received the Pfizer booster on 12/3/21 and within 2 days developed a serious headache and stiff neck that did not go away with OTC pain relievers. I traveled home 12/11-12/12. During this time I began having severe stomach pains and was seen in the emergency room on 12/15/21. The main finding was very elevated liver enzymes. ALT and AST. Over the course of the next 6 months, I was diagnosed with autoimmune hepatitis. I also had a reactivation of EBV, VZ, Cytomegalovirus, and HSV 1. I continue to have extremely high levels of antibodies to each to. I was referred to a neurologist after developing neurological symptoms. I have been told I have a vaccine injury and this has caused autoimmune antibody-mediated small fiber neuropathy and other demyelinating occurrences. I have also developed tachycardia, digestive issues,  and dental problems. I have had CT scans, MRIs, and heart tests, including echocardiogram, blood vessel ultrasound, calcium scoring, and have an upcoming echo stress test. In addition to tachycardia, I have developed cardiovascular symptoms such as weakened blood vessels and bruising. The hepatitis has improved but resulted in a non-diet-related large increase in cholesterol. I am currently on low dose naltrexone, pregabalin, and atorvastatin, as well as a low-dose anti-anxiety medication and valcyclovir. The anxiety comes from the constant health problems and limitations and fear that I will never regain my health as it was prior to this vaccine booster. I am not an anti-vaxxer. I am a biology professor and got vaccinated because vaccines prevent disease. This vaccine, however, has markedly changed my life. I have very bad weeks, with massive inflammation and inability to carry out daily activities. I continue to have neurological symptoms including balance problems and numbness in my extremities. I have better weeks when I am hopeful I will feel well again. I have spent my savings paying for tests, imaging, and specialists. I was unable to work because of this for 8 months and am now financially struggling. I have now gone back to work part time, as I cannot afford not to. I am angry that I trusted that this vaccine was safe and beneficial to my health. I will continue to try to feel better - get the recommended medical tests and take the prescribed medications that have been given me. But, I have lost faith in both the vaccine program and the medical professionals in their ability to treat the vaccine injured. They acknowledge that I was vaccine injured, but admit that they do not know how to treat me. In fact, I have been advised by my doctors to get no vaccines at this time, which leaves me susceptible to influenza, shingles, and pneumonia. This was a health disaster for me. Thank you.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Transient ischaemic attack
Clinical narrative: I don?t know if it is related, but I had a  mini-stroke a month a half after vaccination. I was very healthy before that.
Age: 71.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Fall, Muscular weakness
Clinical narrative: Patient developed extreme weakness of bilateral lower extremities accompanied by low grade fever and elevation in WBCs. Patient sustained 2 falls requiring hospitalization secondary to this weakness
Age: 71.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Patient developed extreme weakness of bilateral lower extremities accompanied by low grade fever and elevation in WBCs. Patient sustained 2 falls requiring hospitalization secondary to this weakness
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Rash macular
Clinical narrative: A few days after the RSV vaccine, my sides from my hips to armpits were covered in a splotchy rash. Like hives but not raised.  There was no pain, they very slowly cleared up over the course of 4-6 weeks.  I sent a picture to my doctor and he has this to say "Could be atypical hives from the RSV vaccine, but it also potentially looks like a benign skin condition called pityriasis rosea.  This is a self-limited rash that can last up to 2 months or so, but does not usually require any treatment.  As it seems to be getting better, I would just ride things out for now".  I looked it up after that and it was similar to online photos but not quite the same.  Got my covid shot 2 weeks later and the nurse said she had a hobby of pitryiasis rosea and her assessment was maybe.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Parotitis
Clinical narrative: Pt called and reports she developed parotitis to parotid gland on right side a few days following the vaccine, seen by pcp, dentist and oral surgeon, treated with oral steroids and antibiotics, symptoms resolving.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered, Injection site irritation, Pyrexia, Wrong product administered
Clinical narrative: The NP ordered an MMR vaccine, but the patient was given an MMR/Varicella combination instead, resulting in the patient receiving a doubled-dose of Varicella Vaccination at the time of vaccination. Resulting symptoms at time of report include fevers and injection-site irritation.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Balance disorder, Head titubation, Headache
Clinical narrative: The patient complained of tremors in the head and hand, knee pain, weakness allover, feeling unbalanced, limbs heavy/solid, thirst, headache, feelings of sleepiness, fever, and aches/pain
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain, Pyrexia, Somnolence, Thirst
Clinical narrative: The patient complained of tremors in the head and hand, knee pain, weakness allover, feeling unbalanced, limbs heavy/solid, thirst, headache, feelings of sleepiness, fever, and aches/pain
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: The patient complained of tremors in the head and hand, knee pain, weakness allover, feeling unbalanced, limbs heavy/solid, thirst, headache, feelings of sleepiness, fever, and aches/pain
Age: 60.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Contusion, Erythema, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Patient got several vaccines on 2/17/24. shingrix, arexy, and prevnar. patient reported/showed pics of both arms being very red and swollen with a rash. Rash on left arm was till evident with right arm showing some bruising. Patient also reported having a fever for a couple days and needing to take ibuprofen. Rph suggest also taking some benadryl to help the rash clear up. Patient did not appear to be in any distress when speaking with rph on 2/24/24. Patient said when she got a covid vaccine before she had a similar issue. I reffered her to her PCP to see if he thought she should get her second shingrix vaccine.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Conjunctivitis, Cough, Eye discharge
Clinical narrative: Cough ongoing for 4 weeks at this point, eye mucous-- conjunctivitis
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pt expericed these side effects the day after her injection (injection date- 2/21/24)  and she said she feels better today  (2/24/24).  The side efffects inclde sore arm, swelling/redness at injection site, diarrhaa, stomach ache, muscle ache,  flu-like symptoms adn otehr symptoms which she did not give details.  Shesaid she felf lousy and very sick.  Shesaid she had to seek a medical advice.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain in extremity
Clinical narrative: Pt expericed these side effects the day after her injection (injection date- 2/21/24)  and she said she feels better today  (2/24/24).  The side efffects inclde sore arm, swelling/redness at injection site, diarrhaa, stomach ache, muscle ache,  flu-like symptoms adn otehr symptoms which she did not give details.  Shesaid she felf lousy and very sick.  Shesaid she had to seek a medical advice.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cancer surgery, Chemotherapy, Computerised tomogram abdomen, Computerised tomogram pelvis, Hysterectomy
Clinical narrative: On 7/27/21, I was injected with the Janssen Covid-19 vaccine.  On 2/11/22, six months later, I was diagnosed with ovarian cancer.  I was told by my oncologist that this was an aggressive cancer and that its onset was about six months prior to the diagnosis.  I believe that the Janssen injection triggered the onset of the cancer.  This resulted in a major surgery to remove the cancer with a full hysterectomy followed by chemotherapy.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ovarian cancer
Clinical narrative: On 7/27/21, I was injected with the Janssen Covid-19 vaccine.  On 2/11/22, six months later, I was diagnosed with ovarian cancer.  I was told by my oncologist that this was an aggressive cancer and that its onset was about six months prior to the diagnosis.  I believe that the Janssen injection triggered the onset of the cancer.  This resulted in a major surgery to remove the cancer with a full hysterectomy followed by chemotherapy.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt was given Pfizer shot - said she was supposed to get flu shot
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt's wife said family was supposed to get flu shots but were given covid
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt wanted flu, was given covid
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Lip swelling
Clinical narrative: Youth had swelling of the lips and c/o feeling dizzy. Youth instructed to elevate legs when lying down and report any further complaints as indicated
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash, Rash erythematous, Skin reaction
Clinical narrative: Saturday got vaccine, sunday woke up with sunburn like rash/skin reaction from covid vaccine. Similar to a bad sunburn and got worse over next 3 days, wrapping around entire arm. Also had itching everywhere with no visible rash.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood creatine phosphokinase, Full blood count, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, warmth and erythema at the injection sight.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Electromyogram, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness
Clinical narrative: On 5/28/2021, the day after receiving the COVID vaccine I experienced weakness in both leds when trying to raise up from squatting, after which I experienced left leg weakness and foot drop.  Went to PCP in July 2021 who did a lumbar xray thinking my leg weakness was due to spinal issues.  After continuing to experience progressive leg weakness I had a lumbar MRI, cervical and thoracic MRI?s, and a brain  MRI performed in addition to 2 EMG tests. Diagnosed with having limb onset ALS on 3/22/2022
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Peroneal nerve palsy
Clinical narrative: On 5/28/2021, the day after receiving the COVID vaccine I experienced weakness in both leds when trying to raise up from squatting, after which I experienced left leg weakness and foot drop.  Went to PCP in July 2021 who did a lumbar xray thinking my leg weakness was due to spinal issues.  After continuing to experience progressive leg weakness I had a lumbar MRI, cervical and thoracic MRI?s, and a brain  MRI performed in addition to 2 EMG tests. Diagnosed with having limb onset ALS on 3/22/2022
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient stated after 2 days she started experiencing to upper right arm warmth, redness, whole upper arm ( by right shoulder) area was hard. patient experienced pain in upper right arm up until 2/23/2024.
Age: 13.0
Sex: M
Vaccine: YF
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Patient was standing for a few minutes after receiving the vaccine when he slowly folded to the ground per mother's statement.  His mother called his name and tapped his face without response.  He then woke up and she guided him to the chair.  I stated that I would call 911 but Mom did not feel it was necessary.   She said that he did not hit his head.   Patient's face was pale but he was responsive.  I left the room to retrieve a bottle of water and notify his father.  After bringing the water, I retrieved an ice pack.  Mom was applying the cold water bottle to patient's face and then replaced the bottle with the ice pack.  Patient stayed seated for a few more minutes and then ate some applesauce and drank more water.   Patient moved to the waiting area and was observed by father.  He continued to stay in the waiting area for another 15 minutes before leaving the store.    Mom reported that he had never fainted after receiving a vaccine; however, he did faint once before after seeing blood.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCIEN FROZEN INSTEAD OF REFRIGERATED
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness & fairly severe pain at injection site that is extending/getting worse
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Chills, headache, low fever, sore throat, body aches. Treated with Tylenol every 6 hours. Symptoms lasted 60+ hours
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Diarrhoea, Dizziness, Fall, Headache
Clinical narrative: 4:15 early morning day after  vaccine, woke feeling nausea, got up to get water. When coming back down hallway completely blacked out and fell to the floor. My husband helped me to bed. When in bed felt like I was going to pass out again. Fell asleep and woke several hours later with severe nausea, diaherra, fever of 101. Severe headache. Over the next few months have very bad headaches. Had a myelogram to check my next from fall. Also several CT scans to check why I was having headaches.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Loss of consciousness, Nausea, Pyrexia, Spinal myelogram
Clinical narrative: 4:15 early morning day after  vaccine, woke feeling nausea, got up to get water. When coming back down hallway completely blacked out and fell to the floor. My husband helped me to bed. When in bed felt like I was going to pass out again. Fell asleep and woke several hours later with severe nausea, diaherra, fever of 101. Severe headache. Over the next few months have very bad headaches. Had a myelogram to check my next from fall. Also several CT scans to check why I was having headaches.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Brain fog, Cardiac monitoring, Chest discomfort, Chest pain
Clinical narrative: Racing heart & heart palpitations, light-headedness, malaise, tremor at the time of the 1st vaccine.  These symptoms were more severe at the time of the 2nd vaccine.  Since then, these symptoms escalated in frequency, intensity, and duration throughout 2021, 2022, 2023, and 2024.  Additional symptoms began to occur in 2023.  In Fall of 2023, I began documenting the symptoms and can add debilitating fatigue, muscle weakness, GI issues, chest pressure and pain, nausea, appetite loss, tinnitus,  spots before my eyes, temperature disregulation, brain fog, and feeling like I'm about to faint.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: Racing heart & heart palpitations, light-headedness, malaise, tremor at the time of the 1st vaccine.  These symptoms were more severe at the time of the 2nd vaccine.  Since then, these symptoms escalated in frequency, intensity, and duration throughout 2021, 2022, 2023, and 2024.  Additional symptoms began to occur in 2023.  In Fall of 2023, I began documenting the symptoms and can add debilitating fatigue, muscle weakness, GI issues, chest pressure and pain, nausea, appetite loss, tinnitus,  spots before my eyes, temperature disregulation, brain fog, and feeling like I'm about to faint.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Malaise, Muscular weakness, Nausea, Palpitations
Clinical narrative: Racing heart & heart palpitations, light-headedness, malaise, tremor at the time of the 1st vaccine.  These symptoms were more severe at the time of the 2nd vaccine.  Since then, these symptoms escalated in frequency, intensity, and duration throughout 2021, 2022, 2023, and 2024.  Additional symptoms began to occur in 2023.  In Fall of 2023, I began documenting the symptoms and can add debilitating fatigue, muscle weakness, GI issues, chest pressure and pain, nausea, appetite loss, tinnitus,  spots before my eyes, temperature disregulation, brain fog, and feeling like I'm about to faint.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature regulation disorder, Tinnitus, Tremor, Visual impairment
Clinical narrative: Racing heart & heart palpitations, light-headedness, malaise, tremor at the time of the 1st vaccine.  These symptoms were more severe at the time of the 2nd vaccine.  Since then, these symptoms escalated in frequency, intensity, and duration throughout 2021, 2022, 2023, and 2024.  Additional symptoms began to occur in 2023.  In Fall of 2023, I began documenting the symptoms and can add debilitating fatigue, muscle weakness, GI issues, chest pressure and pain, nausea, appetite loss, tinnitus,  spots before my eyes, temperature disregulation, brain fog, and feeling like I'm about to faint.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Syncope
Clinical narrative: Fainted for first time ever on 2/23, ran 100 degree temp for a few hours and slept 5 hrs straight. 2/25 site of injection is ref and hot.   Very sore to touch.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Blood test normal, Electromyogram normal, Gait disturbance, Mobility decreased
Clinical narrative: Within 48 hours I developed severe pain in my right thigh.  It soon extended to my right lower back.  I had no pain on my left side.  Prior to receiving the shot, I had been pain-free with a normal gait.  Within 48 hours I was noticeably limping.  I had trouble even rolling over in bed because of the leg and back pain.  ( I had no fever and no generalized body aches, as I had experienced with prior covid shots.)  I continued to be in pain until mid-January, when I sought medical assistance.  On my doctor's instructions, I took vitamin B12 (250 mcg) daily.  Within 48 hours, my pain lessened and within two weeks I was pain-free, with a normal Gail.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Within 48 hours I developed severe pain in my right thigh.  It soon extended to my right lower back.  I had no pain on my left side.  Prior to receiving the shot, I had been pain-free with a normal gait.  Within 48 hours I was noticeably limping.  I had trouble even rolling over in bed because of the leg and back pain.  ( I had no fever and no generalized body aches, as I had experienced with prior covid shots.)  I continued to be in pain until mid-January, when I sought medical assistance.  On my doctor's instructions, I took vitamin B12 (250 mcg) daily.  Within 48 hours, my pain lessened and within two weeks I was pain-free, with a normal Gail.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Nodule, Pain, Swelling
Clinical narrative: knot, redness, swollen, painful
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A third dose of Shingrix was given. No adverse effects were experienced by patient.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: PAIN IN LEFT ARM FROM THE TIME OF THE EVENT AND HAS NOT SUBSIDED
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discomfort, Injection site warmth, Musculoskeletal stiffness, Pain
Clinical narrative: More than 2 weeks after administration of the vaccine the patient was still experiencing overall aches and stiffness and discomfort at the injection. The injection site was still warm to the touch and had a darkened/slight bruised appearance .
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Diarrhoea, Dizziness, Dyspnoea, Exposure during pregnancy
Clinical narrative: Adverse reaction- 12 hours later and lasted for 24 hours.  Lightheaded, extreme bodyaches, diarrhea, anxiety, difficulty breathing, exhaustion but unable to sleep.  35 weeks  3 days pregnant  with 2nd child due 3/22/24.  Did not experience symptoms with previous whooping cough shot in 2022.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain, Sleep disorder
Clinical narrative: Adverse reaction- 12 hours later and lasted for 24 hours.  Lightheaded, extreme bodyaches, diarrhea, anxiety, difficulty breathing, exhaustion but unable to sleep.  35 weeks  3 days pregnant  with 2nd child due 3/22/24.  Did not experience symptoms with previous whooping cough shot in 2022.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Severe thrombocytopenia requiring hospitalization treated with dexamethasone for VIT vs ITP.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning mouth syndrome, Urticaria
Clinical narrative: After 1st dose: no adverse event  After 2nd dose: has been experiencing persistent and on-going "Burning Mouth syndrome" on my lips and tip of the tongue.    After 3rd dose: Experienced  severe cases urticaria in 24h and 2 additional episodes a week apart.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Extreme pain in location of injection and had fever for 2 days.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Injection site urticaria, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Acute setting of hives and erythema near vaccination site.  Concern for normal vaccine reaction versus allergy versus cellulitis.  Erythema localized only to the areas of urticaria, however with significant warmth.  No prior reaction to anthrax vaccine, may have developed a delayed reaction.  Fatigue and other signs and symptoms consistent with a normal reaction to the vaccine.  Given concern for cellulitis, will treat With antibiotics.  No signs or symptoms concerning for anaphylaxis, reassuring.  Also trial antihistamines.  Will send to allergy for further evaluation. May need exemption for further anthrax vaccines in the future  -PRN cetirizine, benadryl  -Keflex 500 mg qid x 5 days  -Allergy referral placed  -ER precautions given  -Follow-up as neededObtained anthrax vaccine 20 Feb, presented to clinic 22 Feb for progressing red wheals at and below injection site. There was a concern for cellulitis, and was started on antibiotics 22 Feb. She went to the ER that night due to fevers and recieved a dose of IV antibiotics.   Also, she did endorse arm pain and fatigue which was similar to her reaction to the last dose of anthrax. But this is her first episode of rash/skin reaction.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Vaccination site urticaria
Clinical narrative: Acute setting of hives and erythema near vaccination site.  Concern for normal vaccine reaction versus allergy versus cellulitis.  Erythema localized only to the areas of urticaria, however with significant warmth.  No prior reaction to anthrax vaccine, may have developed a delayed reaction.  Fatigue and other signs and symptoms consistent with a normal reaction to the vaccine.  Given concern for cellulitis, will treat With antibiotics.  No signs or symptoms concerning for anaphylaxis, reassuring.  Also trial antihistamines.  Will send to allergy for further evaluation. May need exemption for further anthrax vaccines in the future  -PRN cetirizine, benadryl  -Keflex 500 mg qid x 5 days  -Allergy referral placed  -ER precautions given  -Follow-up as neededObtained anthrax vaccine 20 Feb, presented to clinic 22 Feb for progressing red wheals at and below injection site. There was a concern for cellulitis, and was started on antibiotics 22 Feb. She went to the ER that night due to fevers and recieved a dose of IV antibiotics.   Also, she did endorse arm pain and fatigue which was similar to her reaction to the last dose of anthrax. But this is her first episode of rash/skin reaction.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Arthritis, Joint swelling, Muscle spasms, Nausea, Rash
Clinical narrative: Severe rash on arms, back, (primarily upper) legs, face, hands; Swelling & inflammation of joints, especially knees; fever to 99.6 degrees Fahrenheit; mild nausea; Severe lower back cramps.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Pain, Palpitations
Clinical narrative: Day1: extremely tired after a few minutes, 4 hours later, achy and bad headache.  Day 2: high pitched ringing in ears. heart palpitations, headache, tired, stabbing pain in kidney areas.  Day 3: ringing in ears, heart palpitations, red flat itchy rash on neck, chest, back, arms and thighs, headache. Day 4. continuing rash, extreme tiredness, mildly achy, ringing in ears. heart palpitations, on and off.  Day 5: few heart palpitations, tired, mildly achy, very worn out, the red rash comes and goes. It's till itchy.  High pitched ringing in earS. Not listed on data sheet given by the pharmacy. I have gotten this same type of rash with each covid vax.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Tinnitus
Clinical narrative: Day1: extremely tired after a few minutes, 4 hours later, achy and bad headache.  Day 2: high pitched ringing in ears. heart palpitations, headache, tired, stabbing pain in kidney areas.  Day 3: ringing in ears, heart palpitations, red flat itchy rash on neck, chest, back, arms and thighs, headache. Day 4. continuing rash, extreme tiredness, mildly achy, ringing in ears. heart palpitations, on and off.  Day 5: few heart palpitations, tired, mildly achy, very worn out, the red rash comes and goes. It's till itchy.  High pitched ringing in earS. Not listed on data sheet given by the pharmacy. I have gotten this same type of rash with each covid vax.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: Swelling, hard and warm to the touch,  from shoulder to elbow
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Patient uncooperative, Underdose
Clinical narrative: No additional AE; patient who received less than the recommended dose of PROQUAD.; Spontaneous information has been received from a office manager regarding a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 21-FEB-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (exact dose, route, anatomical location not provided) as prophylaxis (with valid lot # X021755, expiration date reported on 23-FEB-2025).  On 21-FEB-2024, the patient moved the arm during the injection and the needle came out and received less than recommended dose (underdose). No injuries or side effects reported, and no additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: experiencing nerve pain; got the shingles this Dec 2023/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In DEC-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shingles this Dec 2023/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: experiencing nerve pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had all the vaccinations that there were for shingles and got the shingles this Dec 2023 and was still experiencing nerve pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: accidentally administered an expired dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HBV (Engerix B) (batch number 9255P, expiry date 15-FEB-2024) for prophylaxis.   On 16-FEB-2024, the patient received Engerix B. On 16-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired dose of Engerix-B). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2024 The healthcare provider stated that the accidently administered an expired dose of Engerix-B to a patient, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 10/17/2023 and a week later received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 29-OCT-2023, the patient received the 2nd dose of Shingrix. On 29-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of Shingrix on 10/17/2023 and a week later received the second dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2024 The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.  The reporter asked, did the patient need to get third dose and how to proceed with series. The reporter consented to follow up.
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient admibnistered 1st dose of Infanrix on 11-Jan-2024 and 2nd on 8-Feb-2024; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old female patient who received DTPa (Infanrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (INFANRIX), ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX).   On 08-FEB-2024, the patient received the 2nd dose of Infanrix. On 08-FEB-2024, an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too short (Verbatim: Patient admibnistered 1st dose of Infanrix on 11-Jan-2024 and 2nd on 8-Feb-2024). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Feb-2024 The physician wanted to report that one of her medical assistant administered on the same clinic day 11th January 2024 Infanrix and Rotarix all liquid formulation vaccines to a 2-months-old baby and after that, on 8th February 2024, on the same clinic day, she administered another Infanrix and Rotarix all liquid formulation to the same baby patient. The patient received 2nd dose of Infanrix , later than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: DTPPVHBHPB, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE.; HCP calling to report 13 year old female received dose of VAXELIS instead of GARDASIL 9.  No adverse effects or any other symptoms or information reported.   Per HCP no product confusion, HCP just grabbed the wrong box.   N/A for GARDASIL 9 product i; Inappropriate age of vaccine administration; This spontaneous report was received from medical assistant and refers to a 13-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-FEB-2024, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, single dose, lot #U7623AA, expiration date: 08-DEC-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age) insted of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) due to grabbed the wrong box (Wrong product administered). No adittional adverse event was reported.
Age: 0.33
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FBE called to report that a nurse reached out to her to tell her that a single dose of PROQUAD was given to a 4 month old patient. FBE has no additional information and will request the Provider reach out directly. FBE has no additional A; FBE has no additional AE information; Varivax was administered to a 4-month-old; This spontaneous report was received from a nurse via company representative and refers to a 4-month-old female. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #X022919, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age.) On 29-JAN-2024, the patient was with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #X022919 expiration date: 12-MAR-2025, administered subcutaneously for prophylaxis (strength, and lot # were not provided) (extra dose administered.)  No additional adverse event was reported.  Lot number X022919 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX.) Lot number X022919 is a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, Injection site swelling
Clinical narrative: Nurse reporting that a patient in their care was seen in their office for a routine vaccination appointment on 1/22/2024, and the patient was inadvertently administered VARIVAX; patient experienced injection site swelling as a result to the administration; This spontaneous report was received from registered nurse and refers to a 4-year-old male. Information regarding the patient's medical history and concomitant therapies was not provided. The patient's concurrent conditions included attention deficit disorder.  On 22-JAN-2024, the patient was going to received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X010526, expiration date: 11-APR-2025, administered intramuscularly for varicella prevention (strength was not provided); but accidentally he also received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X009730, expiration date: 30-SEP-2024, administered intramuscularly for prophylaxis (strength was not provided) (accidental overdose.)   On an unknown date in 2024, the patient experienced patient experienced injection site swelling as a result to the administration. Nurse stated that the patient did not seek any medical attention or treatments for their injection site swelling and confirmed the patient involved has not reported any additional medical concerns or symptoms related to this adverse event. At the time of the report the patient's mother reported that the swelling was still present.  The causal relationship between patient experienced injection site swelling and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reports VARIVAX that expired 2FEB2024 was administered to a patient today; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medication included sterile diluent.  On 08-FEB-2024, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (0.5 milliliter, lot #W003822 was valid, expiration date 02-FEB-2024, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Confirmed no symptoms or side effects reported (No adverse event). Confirmed no temperature excursions on the varicella virus vaccine live (oka/merck) (VARIVAX). Diluent information unknown. No product quality complaint (PQC).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Fungal infection, Rash
Clinical narrative: it went from a rash to an infection and I have a fungus with it; next day I got up I had it (rash) and by the time two days were over it (rash) was all over my body/ next day I started breaking out; and I was broke out all over my body; didn't feel good; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (didn't feel good), FUNGAL INFECTION (it went from a rash to an infection and I have a fungus with it) and RASH (next day I got up I had it (rash) and by the time two days were over it (rash) was all over my body/ next day I started breaking out; and I was broke out all over my body) in an 81-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Poison ivy rash, Hair disorder (Hair falling out), Bullous pemphigoid, Joint pain, Blood pressure high, Latex allergy and Perfume allergy. Concomitant products included FELODIPINE, CLONIDINE, MINOXIDIL and FLUOCINONIDE for an unknown indication.    On 01-Nov-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Nov-2022,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced FEELING ABNORMAL (didn't feel good). On 02-Nov-2022, the patient experienced FUNGAL INFECTION (it went from a rash to an infection and I have a fungus with it) and RASH (next day I got up I had it (rash) and by the time two days were over it (rash) was all over my body/ next day I started breaking out; and I was broke out all over my body). At the time of the report, FEELING ABNORMAL (didn't feel good), FUNGAL INFECTION (it went from a rash to an infection and I have a fungus with it) and RASH (next day I got up I had it (rash) and by the time two days were over it (rash) was all over my body/ next day I started breaking out; and I was broke out all over my body) had not resolved.            Concomitant products included Latex for an unknown indication.  Reportedly, patient did not feel good that night after receiving the Moderna vaccine and the next day got up with rash and by the time two days were over, rash was all over body. Patient started breaking out and was broke out all over body and had been doctoring it ever since November and it went from a rash to an infection and had a fungus with it.  No treatment information was provided.