chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypotension
Clinical narrative: Narrative: Patient reported a severe reaction of shortness of breath and hypotension with their first dose of the COVID-19 vaccine
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Narrative:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Narrative: had pfizer covid 19 vaccine 5/11/2021 and had a bad reaction-red rash around site on left arm and then to axilla, chest, and left side of face. all was on left side where the shot was given. was seen in er. shot was done at pharmacy. had steroids and benadryl in er. no sob, wheezing, or throat swelling; was told not to complete vaccine series; reaction started 2 days after vaccine given
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Swollen tongue
Clinical narrative: Narrative:  41 y.o. female with a history of asthma currently one hour status post first COVID-19 vaccine who now presents to the ED via EMS complaining of itchiness around her shoulders and face, and paraesthesia and swelling on her tongue. She denies shortness of breath. The patient does not report experiencing any associated nausea, vomiting, or diarrhea. To note, she states she has a severe allergy to shellfish and her symptoms today have been similar.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative: COVID19 vaccine unsure of manufacture
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Headache ARM PAIN AND SWELLING Narrative:
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Narrative: Unknown context regarding the adverse event
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Narrative: Patient reported reaction as worsening SOB, dizziness and feeling drugged on the second day after vaccination. He reported that the reaction has subsided. Pt received second dose upon instructions from cardiologist, PT had the same reaction the next day.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Fatigue Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, Fever, exhaustion and chills Narrative:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache BODY ACHES, CHILLS, FATIGUE Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Blister, Breast pain, Chills, Dizziness
Clinical narrative: Terrible symptoms right after the shot, headache, dizzy, pain in arms, pain in armpits and across breast, wanted to throw up if lifted stuff, my arms felt swollen down to palms, Fever, Chills and nausious. Then a month later bilsters on hands and feet. Terrible pain, blistering, crack, peeling, couldn't use regular shampoo burns, couldn't use hand gel sanitizer.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Terrible symptoms right after the shot, headache, dizzy, pain in arms, pain in armpits and across breast, wanted to throw up if lifted stuff, my arms felt swollen down to palms, Fever, Chills and nausious. Then a month later bilsters on hands and feet. Terrible pain, blistering, crack, peeling, couldn't use regular shampoo burns, couldn't use hand gel sanitizer.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation, Skin fissures
Clinical narrative: Terrible symptoms right after the shot, headache, dizzy, pain in arms, pain in armpits and across breast, wanted to throw up if lifted stuff, my arms felt swollen down to palms, Fever, Chills and nausious. Then a month later bilsters on hands and feet. Terrible pain, blistering, crack, peeling, couldn't use regular shampoo burns, couldn't use hand gel sanitizer.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: LEFT ARM VERY SORE, LEFT ARM WEAK, LEFT ARM PAIN WHEN I LIFT ARM, OR MOVE IN ANY MOTION, I HAVE PAIN CONTINUOUSLY, EVERY DAY, EXTREME WEAKNESS WITH ANY ARM MOVEMENT. My left arm continuous pain lack of movement since my Second Moderna Vac shot. I have enclosed my Moderna vaccine records , #1 then #2 then booster.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Motion sickness, Nausea, Vertigo
Clinical narrative: The patient is a 53 yo female with a history of HTN , asthma and morbid obesity who reports a history of severe n/v and vertigo after receipt of COVID Pfizer mRNA vaccine January 29, 21 (EN5318). She denies any immediate reaction to suggest IgE event such as urticaria, pruritis, flushing, oral/face/throat/tongue swelling etc, but did feel a little dizzy, which she attributed to her fasting state at 13:00.  She states she waited her required 15 minutes and drove home. She states she started to feel motion sickness with nausea on the way home. By the time she arrived home she was dizzy with spinning and could not stand and crawled' to her home. She started severe constant vomiting. She denies urticaria, pruritis, oral/face/throat/lip/tongue swelling, flushing, water, red eyes, CP, cough, wheeze, throat tightness. Her family eventually called EMS who treated her with Zofran 8mgs, Benadryl 50 mgs IV and eventually en route with haldol 2mgs which finally helped.  ER  treated with hydration and referred her to Pfizer to discuss future doses. After much paperwork, Pfizer stated the reaction is atypical but did not recommend she receive additional doses.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: The patient is a 53 yo female with a history of HTN , asthma and morbid obesity who reports a history of severe n/v and vertigo after receipt of COVID Pfizer mRNA vaccine January 29, 21 (EN5318). She denies any immediate reaction to suggest IgE event such as urticaria, pruritis, flushing, oral/face/throat/tongue swelling etc, but did feel a little dizzy, which she attributed to her fasting state at 13:00.  She states she waited her required 15 minutes and drove home. She states she started to feel motion sickness with nausea on the way home. By the time she arrived home she was dizzy with spinning and could not stand and crawled' to her home. She started severe constant vomiting. She denies urticaria, pruritis, oral/face/throat/lip/tongue swelling, flushing, water, red eyes, CP, cough, wheeze, throat tightness. Her family eventually called EMS who treated her with Zofran 8mgs, Benadryl 50 mgs IV and eventually en route with haldol 2mgs which finally helped.  ER  treated with hydration and referred her to Pfizer to discuss future doses. After much paperwork, Pfizer stated the reaction is atypical but did not recommend she receive additional doses.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Depression, Rheumatoid arthritis, SARS-CoV-2 antibody test
Clinical narrative: DEPRESSION; ANXIETY; RHEUMATOID ARTHRITIS; COVID INFECTION; This spontaneous report received from a patient concerned an adult female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Prior to vaccination, the patient was completely healthy and physically fit and was exposed to covid in close contact multiple times prior to receiving the vaccine and never had covid verified by multiple negative tests. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) 1 total, dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On Aug-2021, Patient had Covid infection. It was reported that six weeks (On SEP-2021) later the patient began to develop chronic pain in multiple joints which eventually led to a diagnosis of rheumatoid arthritis. The patient had chronic pain and multiple prescription medications that cause various side effects and was likely required to take for the rest of the life, a prognosis of likely disability within a few years, work disruptions and a shortened lifespan, depression and anxiety because of the destruction of health caused by vaccine. Six months following vaccine patient did Covid antibody test on 21-JAN-2022 which showed a positive result of 992 u/ML on a scale where negative was 0.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rheumatoid arthritis, covid infection, depression and anxiety was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220303197- covid-19 vaccine ad26.cov2.s- rheumatoid arthritis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anosmia, Axillary mass, Balance disorder, Breast mass
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Burning sensation, Cardiac flutter, Chills, Cognitive disorder
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Headache, Hyperhidrosis, Hypopnoea, Immune system disorder
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site pain, Injection site swelling, Nausea, Ocular discomfort
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Oropharyngeal pain, Pain, Pain in extremity, Palpitations
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Peripheral swelling, Pyrexia, Rash, Rash pruritic
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tinnitus, Vision blurred
Clinical narrative: Brain Fog, Headache, Sinus Pressure, Loss Of Smell, Fatigue & Exhaustion, Fever, Nausea, Dizziness, And Loss Of Balance, Stomach Pains, Diarrhea, Sweats And Chills, Body Aches, Pain And Swelling Of Injection Site, Shallow And Labored Breathing, Sore Throat, Heart Palpitations, Heart Flutters, Ringing In Ears, Eye Pressure With Blurred Vision, Neck Swelling And Burning, Burning-Itching Rash On Legs And Stomach, Pain And Swelling With Fluid Retention In Both Legs, Swelling And Lumps In Left Armpit And Left Breast, Immune System Weakened, Cognitive Deficiency And Loss Of Ability To Work And Provide For My Family
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Autoinflammatory disease, Chest pain, Chills, Magnetic resonance imaging heart, Myocardial fibrosis
Clinical narrative: Narrative: Patient is a 27 yo female with a PMH of iron deficiency anemia who  presented to the Emergency on 12/1/2021 the day after receiving her  COVID-19 vaccine booster (Pfizer) with chest pain. She reported having chest  pain, chills, and general body aches 8 hours after receiving her vaccine. Initial  toponin I elevated to 0.06, and follow-up 4 hrs later was <0.04. Cardiac MRI  consistent with COVID- 19 vaccine myocarditis. Patient was admitted  (observation status) and placed on tele without evidence of clinically significant  arrhythmia. Cardiology consulted and recommended symptomatic treatment with  NSAIDs. Per the 12/2/21 cardiology consult note, "She probably had myocarditis  from hyperinflammatory state associated with covid vaccine. Fortunately, her  troponin quickly downtrended therefore suggests improvement in the primary  pathology." Patient discharged from observation status on 12/3/21. Per 12/14/21  follow up with her primary care provider, reports being pain free which started 3-  4 days post-observation stay.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pain, Troponin I increased
Clinical narrative: Narrative: Patient is a 27 yo female with a PMH of iron deficiency anemia who  presented to the Emergency on 12/1/2021 the day after receiving her  COVID-19 vaccine booster (Pfizer) with chest pain. She reported having chest  pain, chills, and general body aches 8 hours after receiving her vaccine. Initial  toponin I elevated to 0.06, and follow-up 4 hrs later was <0.04. Cardiac MRI  consistent with COVID- 19 vaccine myocarditis. Patient was admitted  (observation status) and placed on tele without evidence of clinically significant  arrhythmia. Cardiology consulted and recommended symptomatic treatment with  NSAIDs. Per the 12/2/21 cardiology consult note, "She probably had myocarditis  from hyperinflammatory state associated with covid vaccine. Fortunately, her  troponin quickly downtrended therefore suggests improvement in the primary  pathology." Patient discharged from observation status on 12/3/21. Per 12/14/21  follow up with her primary care provider, reports being pain free which started 3-  4 days post-observation stay.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: per death certificate pt died in the ER; cause of death COVID 19; pt had a positive COVID test in the ER
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: pt tested positive for COVID on 11/21/21; was admitted to hosp previously (11/22 - 12/2/21) with COVID that required intubation, was given decadron and remdesivir; was dc'd and is back again on 12/6/21 with worsening respiratory status, weakness, and a wet cough; x-ray shows bilateral pneumonia; steroids and ABX given; pt's condition worsened and he passed away in the hospital
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Death, Dyspnoea, Endotracheal intubation, Feeling abnormal
Clinical narrative: pt tested positive for COVID on 11/21/21; was admitted to hosp previously (11/22 - 12/2/21) with COVID that required intubation, was given decadron and remdesivir; was dc'd and is back again on 12/6/21 with worsening respiratory status, weakness, and a wet cough; x-ray shows bilateral pneumonia; steroids and ABX given; pt's condition worsened and he passed away in the hospital
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Pneumonia, Positive airway pressure therapy, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: pt tested positive for COVID on 11/21/21; was admitted to hosp previously (11/22 - 12/2/21) with COVID that required intubation, was given decadron and remdesivir; was dc'd and is back again on 12/6/21 with worsening respiratory status, weakness, and a wet cough; x-ray shows bilateral pneumonia; steroids and ABX given; pt's condition worsened and he passed away in the hospital
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Septic shock
Clinical narrative: pt tested positive for COVID on 11/21/21; was admitted to hosp previously (11/22 - 12/2/21) with COVID that required intubation, was given decadron and remdesivir; was dc'd and is back again on 12/6/21 with worsening respiratory status, weakness, and a wet cough; x-ray shows bilateral pneumonia; steroids and ABX given; pt's condition worsened and he passed away in the hospital
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Death, Endotracheal intubation, General physical health deterioration
Clinical narrative: pt tested positive for COVID on 11/21/21; was admitted to hosp previously (11/22 - 12/2/21) with COVID that required intubation, was given decadron and remdesivir; was dc'd and is back again on 12/6/21 with worsening respiratory status, weakness, and a wet cough; x-ray shows bilateral pneumonia; steroids and ABX given; pt's condition worsened and he passed away in the hospital
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Productive cough, SARS-CoV-2 test positive, X-ray abnormal
Clinical narrative: pt tested positive for COVID on 11/21/21; was admitted to hosp previously (11/22 - 12/2/21) with COVID that required intubation, was given decadron and remdesivir; was dc'd and is back again on 12/6/21 with worsening respiratory status, weakness, and a wet cough; x-ray shows bilateral pneumonia; steroids and ABX given; pt's condition worsened and he passed away in the hospital
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt presents to ED with increasing SOB, nausea, body aches; positive COVID test in ED; O2 supplementation; required intubation; pt's condition worsened requiring multiple vasopressors; pt did not improve; family made pt DNR/DNI and eventually comfort measures; pt was extubated and passed away in the hospital
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Dyspnoea, Endotracheal intubation, General physical health deterioration
Clinical narrative: pt presents to ED with increasing SOB, nausea, body aches; positive COVID test in ED; O2 supplementation; required intubation; pt's condition worsened requiring multiple vasopressors; pt did not improve; family made pt DNR/DNI and eventually comfort measures; pt was extubated and passed away in the hospital
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test positive
Clinical narrative: pt presents to ED with increasing SOB, nausea, body aches; positive COVID test in ED; O2 supplementation; required intubation; pt's condition worsened requiring multiple vasopressors; pt did not improve; family made pt DNR/DNI and eventually comfort measures; pt was extubated and passed away in the hospital
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Eye pain, Glossodynia, Headache, Pruritus
Clinical narrative: Allergic reaction; Hives; Itching all over; Joint pain; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022 17:30, the patient received the 2nd dose of Shingrix. In February 2022, 19 hrs 30 min after receiving Shingrix, the patient experienced allergic reaction, hives, generalized pruritus and joint pain. The patient was treated with hydroxyzine. On an unknown date, the outcome of the allergic reaction, hives, generalized pruritus and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, hives, generalized pruritus and joint pain to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The reporter reported that the following day at 1 pm, she began experiencing side effects including hives, itching all over and joint pain.  The reporter reported that she went to see her HCP (Health Care Professional) who prescribed an antihistamine hydroxyzine to help with the allergic reaction.  The reporter reported that the symptoms had not yet resolved but were better since taking the medication.  The reporter provided information as per PI (package insert) on clinical studies and adverse reactions.  The reporter consented to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Allergic reaction; Hives; Itching all over; Joint pain; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022 17:30, the patient received the 2nd dose of Shingrix. In February 2022, 19 hrs 30 min after receiving Shingrix, the patient experienced allergic reaction, hives, generalized pruritus and joint pain. The patient was treated with hydroxyzine. On an unknown date, the outcome of the allergic reaction, hives, generalized pruritus and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, hives, generalized pruritus and joint pain to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The reporter reported that the following day at 1 pm, she began experiencing side effects including hives, itching all over and joint pain.  The reporter reported that she went to see her HCP (Health Care Professional) who prescribed an antihistamine hydroxyzine to help with the allergic reaction.  The reporter reported that the symptoms had not yet resolved but were better since taking the medication.  The reporter provided information as per PI (package insert) on clinical studies and adverse reactions.  The reporter consented to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Allergic reaction; Hives; Itching all over; Joint pain; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022 17:30, the patient received the 2nd dose of Shingrix. In February 2022, 19 hrs 30 min after receiving Shingrix, the patient experienced allergic reaction, hives, generalized pruritus and joint pain. The patient was treated with hydroxyzine. On an unknown date, the outcome of the allergic reaction, hives, generalized pruritus and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, hives, generalized pruritus and joint pain to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The reporter reported that the following day at 1 pm, she began experiencing side effects including hives, itching all over and joint pain.  The reporter reported that she went to see her HCP (Health Care Professional) who prescribed an antihistamine hydroxyzine to help with the allergic reaction.  The reporter reported that the symptoms had not yet resolved but were better since taking the medication.  The reporter provided information as per PI (package insert) on clinical studies and adverse reactions.  The reporter consented to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardio-respiratory arrest, Dizziness, Dyspnoea, Dyspnoea exertional, Heart rate increased
Clinical narrative: About 10  min after vaccination patient c/o feeling not right, light headed, palpitations, feeling her throat closing, feelings of anxiety, flushing of the face and neck. BP 199/79 Pulse 105 Spo2 100% Code Blue called and transferred to ED from Immunization room.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pharyngeal swelling, Swelling face
Clinical narrative: About 10  min after vaccination patient c/o feeling not right, light headed, palpitations, feeling her throat closing, feelings of anxiety, flushing of the face and neck. BP 199/79 Pulse 105 Spo2 100% Code Blue called and transferred to ED from Immunization room.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Cardio-respiratory arrest, Dizziness, Feeling abnormal, Flushing
Clinical narrative: About 10  min after vaccination patient c/o feeling not right, light headed, palpitations, feeling her throat closing, feelings of anxiety, flushing of the face and neck. BP 199/79 Pulse 105 Spo2 100% Code Blue called and transferred to ED from Immunization room.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations, Rash erythematous, Throat irritation, Throat tightness
Clinical narrative: About 10  min after vaccination patient c/o feeling not right, light headed, palpitations, feeling her throat closing, feelings of anxiety, flushing of the face and neck. BP 199/79 Pulse 105 Spo2 100% Code Blue called and transferred to ED from Immunization room.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Exposure to SARS-CoV-2, Nausea, Pyrexia
Clinical narrative: Hospitalized with increased dyspnea, fatigue, weakness Expired
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Death, Dyspnoea, Fatigue
Clinical narrative: Hospitalized with increased dyspnea, fatigue, weakness Expired
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Dyspnoea, Resuscitation, Syncope, Wheezing
Clinical narrative: Unexpected Patient Death:  This was an 81 yo male, seen at his primary care physician office with complaints of shortness of breath and wheezing.  Breathing has worsened since completing a prednisone course 2 weeks prior, which had been started on 1/18/22 in the Emergency Department for a COPD exacerbation.  During the visit, his sister (who serves as his caregiver) requested a COVID-19 vaccine booster.  No contraindications to vaccine were identified an a Pfizer vaccine was adminstered.  Previous vaccination with Covid-19 vaccines were completed with Moderna (dose #1 on 3/9/2021 with lot#048A21A; dose #2 on 4/6/2021 with lot#038A21A).   Patient received Pfizer booster at 1502 and was then escorted into the lobby for 15 minute observation period.  The patient had no prior reactions/adverse effects to covid-19 vaccines.  At 1515, the patient and his sister exited the lobby and walked toward their car.  The sister reports the patient 'looked out of it' and then collapsed.   A bystander in the parking immediately responded and began CPR.  Clinic staff was notified and also immediately responded.  An AED was placed and no shock was indicated so CPR resumed.  EMS arrived within 5 minutes and patient was transported to a nearby hospital.  Our clinic team was then notified that the code was called and the patient had expired.  Causality with vaccine is unknown.  Final cause of death is unknown at this time.   Reporting unexpected death following vaccination as required in EUA.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac assistance device user, Cardio-respiratory arrest, Death, Dyspnoea, General physical condition abnormal
Clinical narrative: Unexpected Patient Death:  This was an 81 yo male, seen at his primary care physician office with complaints of shortness of breath and wheezing.  Breathing has worsened since completing a prednisone course 2 weeks prior, which had been started on 1/18/22 in the Emergency Department for a COPD exacerbation.  During the visit, his sister (who serves as his caregiver) requested a COVID-19 vaccine booster.  No contraindications to vaccine were identified an a Pfizer vaccine was adminstered.  Previous vaccination with Covid-19 vaccines were completed with Moderna (dose #1 on 3/9/2021 with lot#048A21A; dose #2 on 4/6/2021 with lot#038A21A).   Patient received Pfizer booster at 1502 and was then escorted into the lobby for 15 minute observation period.  The patient had no prior reactions/adverse effects to covid-19 vaccines.  At 1515, the patient and his sister exited the lobby and walked toward their car.  The sister reports the patient 'looked out of it' and then collapsed.   A bystander in the parking immediately responded and began CPR.  Clinic staff was notified and also immediately responded.  An AED was placed and no shock was indicated so CPR resumed.  EMS arrived within 5 minutes and patient was transported to a nearby hospital.  Our clinic team was then notified that the code was called and the patient had expired.  Causality with vaccine is unknown.  Final cause of death is unknown at this time.   Reporting unexpected death following vaccination as required in EUA.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Respiration abnormal, Resuscitation, Syncope, Wheezing
Clinical narrative: Unexpected Patient Death:  This was an 81 yo male, seen at his primary care physician office with complaints of shortness of breath and wheezing.  Breathing has worsened since completing a prednisone course 2 weeks prior, which had been started on 1/18/22 in the Emergency Department for a COPD exacerbation.  During the visit, his sister (who serves as his caregiver) requested a COVID-19 vaccine booster.  No contraindications to vaccine were identified an a Pfizer vaccine was adminstered.  Previous vaccination with Covid-19 vaccines were completed with Moderna (dose #1 on 3/9/2021 with lot#048A21A; dose #2 on 4/6/2021 with lot#038A21A).   Patient received Pfizer booster at 1502 and was then escorted into the lobby for 15 minute observation period.  The patient had no prior reactions/adverse effects to covid-19 vaccines.  At 1515, the patient and his sister exited the lobby and walked toward their car.  The sister reports the patient 'looked out of it' and then collapsed.   A bystander in the parking immediately responded and began CPR.  Clinic staff was notified and also immediately responded.  An AED was placed and no shock was indicated so CPR resumed.  EMS arrived within 5 minutes and patient was transported to a nearby hospital.  Our clinic team was then notified that the code was called and the patient had expired.  Causality with vaccine is unknown.  Final cause of death is unknown at this time.   Reporting unexpected death following vaccination as required in EUA.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration, Injection site granuloma, Injection site haemorrhage, Pyogenic granuloma, Skin lesion
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: Mom reports pt having blood bolus develop 2 weeks after receiving COVID vaccine booster.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: Mom reports pt having blood bolus develop 2 weeks after receiving COVID vaccine booster.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: Mom reports pt having blood bolus develop 2 weeks after receiving COVID vaccine booster.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Ligament sprain
Clinical narrative: "Patient is a 14 y.o. female  with ADHD  who presents with leg weakness, gait disturbance resulting in multiple falls, and right foot paresthesias.   Of note, patient recently had right foot sprain after kickboxing on 1/25. This was thoroughly worked up with both X-rays and MRI and was normal. She had briefly used a post-op shoe but that made the pain worse. The pain had been in the arch of her right foot and that has improved but now she is having pain over the ball of the foot and with associated intermittent paresthesias of ball and toes. Over the last 2 weeks she has had leg weakness and difficulty walking. Her symptoms seem to be worst in the morning and she is now unable to get herself dressed. It's difficult for her to get from sitting to standing by herself. She was provided with crutches but has fallen with those so now is using a scooter. She pushes the scooter with her left leg. In general, she has been having progressively more falls over the past 2 weeks with 2 falls yesterday. She has not hit her head or lost consciousness with any of her falls. Otherwise she denies any other change in her symptoms over this time period.   She has not had any change in bladder or bowel function and denies saddle paresthesia. No ataxia or true numbness. No difficulty breathing or swallowing. She has not had any confusion or altered behavior. She denies headaches or vision changes and she has not experienced any back or neck pain.   No recent fevers or sick symptoms over the past 2 months. She did receive her COVID-19 booster (Pfizer) on 1/13. Of note, she has had 10 lbs of unintentional weight loss over past 6 weeks and she feels she is eating just as well as she was prior to this. She has been trying to supplement with protein shakes but has continued to lose weight. Denies any night sweats or cough. She also reports some anxiety revolving around her current symptoms, especially related to falling or being alone. She had some sleep disturbance related to her initial foot injury in January but has been sleeping well over the past few weeks."
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: "Patient is a 14 y.o. female  with ADHD  who presents with leg weakness, gait disturbance resulting in multiple falls, and right foot paresthesias.   Of note, patient recently had right foot sprain after kickboxing on 1/25. This was thoroughly worked up with both X-rays and MRI and was normal. She had briefly used a post-op shoe but that made the pain worse. The pain had been in the arch of her right foot and that has improved but now she is having pain over the ball of the foot and with associated intermittent paresthesias of ball and toes. Over the last 2 weeks she has had leg weakness and difficulty walking. Her symptoms seem to be worst in the morning and she is now unable to get herself dressed. It's difficult for her to get from sitting to standing by herself. She was provided with crutches but has fallen with those so now is using a scooter. She pushes the scooter with her left leg. In general, she has been having progressively more falls over the past 2 weeks with 2 falls yesterday. She has not hit her head or lost consciousness with any of her falls. Otherwise she denies any other change in her symptoms over this time period.   She has not had any change in bladder or bowel function and denies saddle paresthesia. No ataxia or true numbness. No difficulty breathing or swallowing. She has not had any confusion or altered behavior. She denies headaches or vision changes and she has not experienced any back or neck pain.   No recent fevers or sick symptoms over the past 2 months. She did receive her COVID-19 booster (Pfizer) on 1/13. Of note, she has had 10 lbs of unintentional weight loss over past 6 weeks and she feels she is eating just as well as she was prior to this. She has been trying to supplement with protein shakes but has continued to lose weight. Denies any night sweats or cough. She also reports some anxiety revolving around her current symptoms, especially related to falling or being alone. She had some sleep disturbance related to her initial foot injury in January but has been sleeping well over the past few weeks."
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abnormal loss of weight, Accident, Anxiety, Dysstasia, Fall
Clinical narrative: "Patient is a 14 y.o. female  with ADHD  who presents with leg weakness, gait disturbance resulting in multiple falls, and right foot paresthesias.   Of note, patient recently had right foot sprain after kickboxing on 1/25. This was thoroughly worked up with both X-rays and MRI and was normal. She had briefly used a post-op shoe but that made the pain worse. The pain had been in the arch of her right foot and that has improved but now she is having pain over the ball of the foot and with associated intermittent paresthesias of ball and toes. Over the last 2 weeks she has had leg weakness and difficulty walking. Her symptoms seem to be worst in the morning and she is now unable to get herself dressed. It's difficult for her to get from sitting to standing by herself. She was provided with crutches but has fallen with those so now is using a scooter. She pushes the scooter with her left leg. In general, she has been having progressively more falls over the past 2 weeks with 2 falls yesterday. She has not hit her head or lost consciousness with any of her falls. Otherwise she denies any other change in her symptoms over this time period.   She has not had any change in bladder or bowel function and denies saddle paresthesia. No ataxia or true numbness. No difficulty breathing or swallowing. She has not had any confusion or altered behavior. She denies headaches or vision changes and she has not experienced any back or neck pain.   No recent fevers or sick symptoms over the past 2 months. She did receive her COVID-19 booster (Pfizer) on 1/13. Of note, she has had 10 lbs of unintentional weight loss over past 6 weeks and she feels she is eating just as well as she was prior to this. She has been trying to supplement with protein shakes but has continued to lose weight. Denies any night sweats or cough. She also reports some anxiety revolving around her current symptoms, especially related to falling or being alone. She had some sleep disturbance related to her initial foot injury in January but has been sleeping well over the past few weeks."
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Intervertebral disc degeneration, Ligament sprain, Loss of personal independence in daily activities, Magnetic resonance imaging spinal abnormal
Clinical narrative: "Patient is a 14 y.o. female  with ADHD  who presents with leg weakness, gait disturbance resulting in multiple falls, and right foot paresthesias.   Of note, patient recently had right foot sprain after kickboxing on 1/25. This was thoroughly worked up with both X-rays and MRI and was normal. She had briefly used a post-op shoe but that made the pain worse. The pain had been in the arch of her right foot and that has improved but now she is having pain over the ball of the foot and with associated intermittent paresthesias of ball and toes. Over the last 2 weeks she has had leg weakness and difficulty walking. Her symptoms seem to be worst in the morning and she is now unable to get herself dressed. It's difficult for her to get from sitting to standing by herself. She was provided with crutches but has fallen with those so now is using a scooter. She pushes the scooter with her left leg. In general, she has been having progressively more falls over the past 2 weeks with 2 falls yesterday. She has not hit her head or lost consciousness with any of her falls. Otherwise she denies any other change in her symptoms over this time period.   She has not had any change in bladder or bowel function and denies saddle paresthesia. No ataxia or true numbness. No difficulty breathing or swallowing. She has not had any confusion or altered behavior. She denies headaches or vision changes and she has not experienced any back or neck pain.   No recent fevers or sick symptoms over the past 2 months. She did receive her COVID-19 booster (Pfizer) on 1/13. Of note, she has had 10 lbs of unintentional weight loss over past 6 weeks and she feels she is eating just as well as she was prior to this. She has been trying to supplement with protein shakes but has continued to lose weight. Denies any night sweats or cough. She also reports some anxiety revolving around her current symptoms, especially related to falling or being alone. She had some sleep disturbance related to her initial foot injury in January but has been sleeping well over the past few weeks."
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Radiculopathy, Sleep disorder
Clinical narrative: "Patient is a 14 y.o. female  with ADHD  who presents with leg weakness, gait disturbance resulting in multiple falls, and right foot paresthesias.   Of note, patient recently had right foot sprain after kickboxing on 1/25. This was thoroughly worked up with both X-rays and MRI and was normal. She had briefly used a post-op shoe but that made the pain worse. The pain had been in the arch of her right foot and that has improved but now she is having pain over the ball of the foot and with associated intermittent paresthesias of ball and toes. Over the last 2 weeks she has had leg weakness and difficulty walking. Her symptoms seem to be worst in the morning and she is now unable to get herself dressed. It's difficult for her to get from sitting to standing by herself. She was provided with crutches but has fallen with those so now is using a scooter. She pushes the scooter with her left leg. In general, she has been having progressively more falls over the past 2 weeks with 2 falls yesterday. She has not hit her head or lost consciousness with any of her falls. Otherwise she denies any other change in her symptoms over this time period.   She has not had any change in bladder or bowel function and denies saddle paresthesia. No ataxia or true numbness. No difficulty breathing or swallowing. She has not had any confusion or altered behavior. She denies headaches or vision changes and she has not experienced any back or neck pain.   No recent fevers or sick symptoms over the past 2 months. She did receive her COVID-19 booster (Pfizer) on 1/13. Of note, she has had 10 lbs of unintentional weight loss over past 6 weeks and she feels she is eating just as well as she was prior to this. She has been trying to supplement with protein shakes but has continued to lose weight. Denies any night sweats or cough. She also reports some anxiety revolving around her current symptoms, especially related to falling or being alone. She had some sleep disturbance related to her initial foot injury in January but has been sleeping well over the past few weeks."
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Walking aid user, X-ray normal
Clinical narrative: "Patient is a 14 y.o. female  with ADHD  who presents with leg weakness, gait disturbance resulting in multiple falls, and right foot paresthesias.   Of note, patient recently had right foot sprain after kickboxing on 1/25. This was thoroughly worked up with both X-rays and MRI and was normal. She had briefly used a post-op shoe but that made the pain worse. The pain had been in the arch of her right foot and that has improved but now she is having pain over the ball of the foot and with associated intermittent paresthesias of ball and toes. Over the last 2 weeks she has had leg weakness and difficulty walking. Her symptoms seem to be worst in the morning and she is now unable to get herself dressed. It's difficult for her to get from sitting to standing by herself. She was provided with crutches but has fallen with those so now is using a scooter. She pushes the scooter with her left leg. In general, she has been having progressively more falls over the past 2 weeks with 2 falls yesterday. She has not hit her head or lost consciousness with any of her falls. Otherwise she denies any other change in her symptoms over this time period.   She has not had any change in bladder or bowel function and denies saddle paresthesia. No ataxia or true numbness. No difficulty breathing or swallowing. She has not had any confusion or altered behavior. She denies headaches or vision changes and she has not experienced any back or neck pain.   No recent fevers or sick symptoms over the past 2 months. She did receive her COVID-19 booster (Pfizer) on 1/13. Of note, she has had 10 lbs of unintentional weight loss over past 6 weeks and she feels she is eating just as well as she was prior to this. She has been trying to supplement with protein shakes but has continued to lose weight. Denies any night sweats or cough. She also reports some anxiety revolving around her current symptoms, especially related to falling or being alone. She had some sleep disturbance related to her initial foot injury in January but has been sleeping well over the past few weeks."
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pt was given a dose from a vial that was >12 hour post puncture. Vial was left at room temp at 6pm and pt was given dose at around 10:20am. Pt was informed of error and pt reported feeling "bad" after receiving shot. She states cold like symptoms, fever, chills, headache started the same evening (Friday) that she received the shot and was gone by Sunday evening, except for the headache. Headache has not gone away and has been ongoing 24/7. Pt has an upcoming appointment with her physician in about a week.