chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume increased
Clinical narrative: Diagnosis, Assessment & Plan  - Free Text A&P Free Text A&P:   Assessment: Suspected bullous pemphigoid secondary to influenza vaccination Scattered pruritic annular erythematous urticarial rash with bulla Hypertension Hyperlipidemia Iron deficiency anemia   Plan: Scattered pruritic annular erythematous urticarial rash with blister/bulla following vaccination; we favor bullous pemphigoid over erythema multiforme or serum sickness. Recommend skin biopsy and testing (surgery consulted and tentative plan to biopsy on Monday when pathology is back); direct and indirect immunofluorescence to confirm the diagnosis. Concerns raised of possible antibiotic allergy or side effect, which is less likely, but ok to hold abx and monitor on steroids. Tentative plan at DC would be to resume PO Doxy to finish 10 day course.  Recommend oral steroids x10-14 days total course with taper thereafter (can also consider additional topical steroid). Would recommend reporting to VAERS if not already done, defer to hospital protocol/personnel.   <- Last Filed: 12/18/23 10:15>
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Monocyte count normal, Monocyte percentage, Pemphigoid, Platelet count normal, Protein total decreased
Clinical narrative: Diagnosis, Assessment & Plan  - Free Text A&P Free Text A&P:   Assessment: Suspected bullous pemphigoid secondary to influenza vaccination Scattered pruritic annular erythematous urticarial rash with bulla Hypertension Hyperlipidemia Iron deficiency anemia   Plan: Scattered pruritic annular erythematous urticarial rash with blister/bulla following vaccination; we favor bullous pemphigoid over erythema multiforme or serum sickness. Recommend skin biopsy and testing (surgery consulted and tentative plan to biopsy on Monday when pathology is back); direct and indirect immunofluorescence to confirm the diagnosis. Concerns raised of possible antibiotic allergy or side effect, which is less likely, but ok to hold abx and monitor on steroids. Tentative plan at DC would be to resume PO Doxy to finish 10 day course.  Recommend oral steroids x10-14 days total course with taper thereafter (can also consider additional topical steroid). Would recommend reporting to VAERS if not already done, defer to hospital protocol/personnel.   <- Last Filed: 12/18/23 10:15>
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular, Red blood cell count decreased, Red blood cell nucleated morphology
Clinical narrative: Diagnosis, Assessment & Plan  - Free Text A&P Free Text A&P:   Assessment: Suspected bullous pemphigoid secondary to influenza vaccination Scattered pruritic annular erythematous urticarial rash with bulla Hypertension Hyperlipidemia Iron deficiency anemia   Plan: Scattered pruritic annular erythematous urticarial rash with blister/bulla following vaccination; we favor bullous pemphigoid over erythema multiforme or serum sickness. Recommend skin biopsy and testing (surgery consulted and tentative plan to biopsy on Monday when pathology is back); direct and indirect immunofluorescence to confirm the diagnosis. Concerns raised of possible antibiotic allergy or side effect, which is less likely, but ok to hold abx and monitor on steroids. Tentative plan at DC would be to resume PO Doxy to finish 10 day course.  Recommend oral steroids x10-14 days total course with taper thereafter (can also consider additional topical steroid). Would recommend reporting to VAERS if not already done, defer to hospital protocol/personnel.   <- Last Filed: 12/18/23 10:15>
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Red cell distribution width normal, Serum sickness, Urticaria, White blood cell count normal
Clinical narrative: Diagnosis, Assessment & Plan  - Free Text A&P Free Text A&P:   Assessment: Suspected bullous pemphigoid secondary to influenza vaccination Scattered pruritic annular erythematous urticarial rash with bulla Hypertension Hyperlipidemia Iron deficiency anemia   Plan: Scattered pruritic annular erythematous urticarial rash with blister/bulla following vaccination; we favor bullous pemphigoid over erythema multiforme or serum sickness. Recommend skin biopsy and testing (surgery consulted and tentative plan to biopsy on Monday when pathology is back); direct and indirect immunofluorescence to confirm the diagnosis. Concerns raised of possible antibiotic allergy or side effect, which is less likely, but ok to hold abx and monitor on steroids. Tentative plan at DC would be to resume PO Doxy to finish 10 day course.  Recommend oral steroids x10-14 days total course with taper thereafter (can also consider additional topical steroid). Would recommend reporting to VAERS if not already done, defer to hospital protocol/personnel.   <- Last Filed: 12/18/23 10:15>
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose of Havrix (expired yesterday) was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-month-old male patient who received HAV (Havrix 720) (batch number 2YZ9B, expiry date 07-DEC-2023) for prophylaxis.   On 08-DEC-2023, the patient received the 1st dose of Havrix 720. On 08-DEC-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: an expired dose of Havrix (expired yesterday) was administered). The outcome of the expired vaccine used 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- 08-DEC-2023 The nurse reported that an expired dose of Havrix vaccine was administered, which led to expired vaccine used The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: an expired dose of Boostrix was administered to a patient; 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 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 11-DEC-2023, the patient received Boostrix. On 11-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Boostrix was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: RA receipt date: 11-DEC-2023 The reporter is other health professional. The hcp reported that, an expired dose of Boostrix was administered to a patient today which led to expired vaccine used. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administration of a dose of Menveo where the diluent had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date 30-NOV-2023) and (batch number AMXA751A, expiry date 31-OCT-2024) for prophylaxis.   On 05-DEC-2023, the patient received the 2nd dose of Menveo. On 05-DEC-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administration of a dose of Menveo where the diluent had expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-DEC-2023 Reporter was the nurse. The reporter inquiring about Menveo and what information was available about the administration of a dose of Menveo where the diluent had expired. The reporter stated that information about the vaccine, patient, and event was collected. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: extra dose of Arexvy was given 1 week after the initial one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 84-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 11-DEC-2023, the patient received the 2nd dose of Arexvy. On 11-DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: extra dose of Arexvy was given 1 week after the initial one). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 11-DEC-2023 A Pharmacist inquiring about Arexvy and what information was available about safety and immunogenicity data when an extra dose of Arexvy was given 1 week after the initial one which led to extra dose administered.  The pharmacist gave partial information about the vaccine, event, and patient.  The reporter consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received the first dose of Engerix on 5/24/23 and the second dose on 6/26/23, currently 2 weeks late for the third dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose of Engerix B on 24-MAY-2023) and Engerix B (received second dose of Engerix B on 26-JUN-2023).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: a patient received the first dose of Engerix on 5/24/23 and the second dose on 6/26/23, currently 2 weeks late for the third dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-DEC-2023 The registered nurse reported patient was currently 2 weeks late for the third dose. The registered nurse wanted to know if any guidance and how to proceed with the third dose of Engerix B. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. The reporter declined follow up from safety.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Chills and body aches  * severe joint pain I?d describe it as someone poured cement into my joints and then lit them on fire.  Knees, ankles BUT the worse was my elbows and wrists. Forearms very sore also. By Sunday symptoms of joint pain are better but wrist and elbows are still sore.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My grandmother DIED after receiving your stupid vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (My grandmother DIED after receiving your stupid vaccine) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. Death occurred on 10-Dec-2023 The patient died on 10-Dec-2023. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  Reporter mentioned that patient died 17 hours ago. Reporter had to watch patient died in the ICU.  Treatment information was not reported. Company Comment: This is a spontaneous case concerning a female patient of an unknown age, with no reported medical history, who experienced the serious (due to medically significant, life-threatening, hospitalization) fatal, unexpected, event of Death, which occurred with unknown latency after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. The patient died on 10-Dec-2023. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; improperly stored vaccine; This spontaneous report was received from a paramedic and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date, the varicella virus vaccine live (oka/merck) (VARIVAX) had a temperature excursion showed 5.6 degree Celsius (C) for 3 hours.  On 16-NOV-2023, the patient was vaccinated with the improper stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X017486 was verified as a valid lot number, expiration date: 25-JUN-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (product storage error). The paramedic had not reported any symptoms or additional adverse events (no adverse event). It was reported that there was no previous temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient not recived 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on NOV-2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient not recived 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA receipt date: 08-DEC-2023 The reporter was the Pharmacist. The reporter reported that 2 patients (husband and wife) received 1st dose Shingrix vaccine on November 2020 Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up. This case was linked with the case US2023172467 reported by same reporter.; Sender's Comments:  US-GSK-US2023172467:Male patient case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Vaccination site joint movement impairment
Clinical narrative: Within 4 days I felt soreness in both of my shoulder joints. It progressed to feeling similar to bursitis or arthritis; I was sick with a 103 fever the night of the vaccine and it took 2 days for me to feel better, then I have this joint issue.; I could barely raise my arms and it was painful. Today (12-Dec-2023) it feels better but still not normal at all.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (I could barely raise my arms and it was painful. Today (12-Dec-2023) it feels better but still not normal at all.), ARTHRALGIA (Within 4 days I felt soreness in both of my shoulder joints. It progressed to feeling similar to bursitis or arthritis) and PYREXIA (I was sick with a 103 fever the night of the vaccine and it took 2 days for me to feel better, then I have this joint issue.) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. In 2023, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (I could barely raise my arms and it was painful. Today (12-Dec-2023) it feels better but still not normal at all.). In November 2023, the patient experienced PYREXIA (I was sick with a 103 fever the night of the vaccine and it took 2 days for me to feel better, then I have this joint issue.). On 20-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ARTHRALGIA (Within 4 days I felt soreness in both of my shoulder joints. It progressed to feeling similar to bursitis or arthritis). In November 2023, PYREXIA (I was sick with a 103 fever the night of the vaccine and it took 2 days for me to feel better, then I have this joint issue.) had resolved. At the time of the report, VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (I could barely raise my arms and it was painful. Today (12-Dec-2023) it feels better but still not normal at all.) and ARTHRALGIA (Within 4 days I felt soreness in both of my shoulder joints. It progressed to feeling similar to bursitis or arthritis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Body temperature: 103.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medication use information was not provided by reporter.  Patient had no history of either. Patient did not think for getting another shot. Patient was healthy and did not take daily meds and had no history of anything like this and after the shot it popped up in both arms at the same time.   It was unknown if the patient experienced any additional symptoms/events.  Treatment medication use information was not provided by reporter.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Headache, Pain
Clinical narrative: About  45 minutes  after injections I became short of breath, itchy all over my body,  tingling in lips, coughing. These symptoms last about 30 minutes. No other symptoms the remainder of 12/16/23.  In the middle of the night I had chills. When I work up on 12/17/23 I had a bad headache, body aches.  Body aches remained until I woke up on 12/18/23.  I received the Moderna spikevax
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: About  45 minutes  after injections I became short of breath, itchy all over my body,  tingling in lips, coughing. These symptoms last about 30 minutes. No other symptoms the remainder of 12/16/23.  In the middle of the night I had chills. When I work up on 12/17/23 I had a bad headache, body aches.  Body aches remained until I woke up on 12/18/23.  I received the Moderna spikevax
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arteriogram coronary normal, Arthralgia, Cardiac stress test, Dizziness
Clinical narrative: Extreme fatigue, dizziness, syncope, headache, joint pain, heart palpitations, tachycardia, fluctuating heart rate, GI upset, shortness of breath with exertion, intolerance to heat, visual disturbance and muscle weakness impacting all activities of daily life, worsening after the 3rd dose of the Pfizer BioNTech received on 12/21/2021 with lot# FL3198. Prior to the Covid-19 vaccines, patient was a healthy young woman, who lived a very independent life,. and was preparing to serve a mission for her church and attend college. Unfortunately, patient was unable to serve her mission, and has had to resort to online school. Patient has become completely dependent on her mother for transportation, cooking, cleaning, and shopping.and is no longer able to enjoy being outside due to her intolerance to the heat. All of which she was able to do on her own prior to the vaccines. Patient has to take a minimum of a 2 hour nap daily due to extreme fatigue. Patient continues to suffer from these symptoms which have increased within the last 2-3 weeks (November/December 2023). Patient has tried and failed fludrocortisone and Midodrine due to drug allergies. Dr., Interventional Cardiologist,  has recommend she be treated at the Autonomic Dysfunction Clinic, who has developed a treatment for this condition. However, due to insurance deficiencies with no out of network coverage, and denial of preauthorization from insurance, patient continues to go without treatment and is beginning to decline more rapidly from her symptoms. There are no in-network providers who are treating for Covid-19 Vaccine injuries. Clinic requires a $5,000 cash deposit to begin treatment, money I do not have access to. I continue to appeal insurance, and thus far, have been unsuccessful.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dyspnoea exertional, Echocardiogram abnormal, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Extreme fatigue, dizziness, syncope, headache, joint pain, heart palpitations, tachycardia, fluctuating heart rate, GI upset, shortness of breath with exertion, intolerance to heat, visual disturbance and muscle weakness impacting all activities of daily life, worsening after the 3rd dose of the Pfizer BioNTech received on 12/21/2021 with lot# FL3198. Prior to the Covid-19 vaccines, patient was a healthy young woman, who lived a very independent life,. and was preparing to serve a mission for her church and attend college. Unfortunately, patient was unable to serve her mission, and has had to resort to online school. Patient has become completely dependent on her mother for transportation, cooking, cleaning, and shopping.and is no longer able to enjoy being outside due to her intolerance to the heat. All of which she was able to do on her own prior to the vaccines. Patient has to take a minimum of a 2 hour nap daily due to extreme fatigue. Patient continues to suffer from these symptoms which have increased within the last 2-3 weeks (November/December 2023). Patient has tried and failed fludrocortisone and Midodrine due to drug allergies. Dr., Interventional Cardiologist,  has recommend she be treated at the Autonomic Dysfunction Clinic, who has developed a treatment for this condition. However, due to insurance deficiencies with no out of network coverage, and denial of preauthorization from insurance, patient continues to go without treatment and is beginning to decline more rapidly from her symptoms. There are no in-network providers who are treating for Covid-19 Vaccine injuries. Clinic requires a $5,000 cash deposit to begin treatment, money I do not have access to. I continue to appeal insurance, and thus far, have been unsuccessful.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise electrocardiogram, Fatigue, General physical health deterioration, Headache, Heart rate irregular
Clinical narrative: Extreme fatigue, dizziness, syncope, headache, joint pain, heart palpitations, tachycardia, fluctuating heart rate, GI upset, shortness of breath with exertion, intolerance to heat, visual disturbance and muscle weakness impacting all activities of daily life, worsening after the 3rd dose of the Pfizer BioNTech received on 12/21/2021 with lot# FL3198. Prior to the Covid-19 vaccines, patient was a healthy young woman, who lived a very independent life,. and was preparing to serve a mission for her church and attend college. Unfortunately, patient was unable to serve her mission, and has had to resort to online school. Patient has become completely dependent on her mother for transportation, cooking, cleaning, and shopping.and is no longer able to enjoy being outside due to her intolerance to the heat. All of which she was able to do on her own prior to the vaccines. Patient has to take a minimum of a 2 hour nap daily due to extreme fatigue. Patient continues to suffer from these symptoms which have increased within the last 2-3 weeks (November/December 2023). Patient has tried and failed fludrocortisone and Midodrine due to drug allergies. Dr., Interventional Cardiologist,  has recommend she be treated at the Autonomic Dysfunction Clinic, who has developed a treatment for this condition. However, due to insurance deficiencies with no out of network coverage, and denial of preauthorization from insurance, patient continues to go without treatment and is beginning to decline more rapidly from her symptoms. There are no in-network providers who are treating for Covid-19 Vaccine injuries. Clinic requires a $5,000 cash deposit to begin treatment, money I do not have access to. I continue to appeal insurance, and thus far, have been unsuccessful.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Insurance issue, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Muscular weakness
Clinical narrative: Extreme fatigue, dizziness, syncope, headache, joint pain, heart palpitations, tachycardia, fluctuating heart rate, GI upset, shortness of breath with exertion, intolerance to heat, visual disturbance and muscle weakness impacting all activities of daily life, worsening after the 3rd dose of the Pfizer BioNTech received on 12/21/2021 with lot# FL3198. Prior to the Covid-19 vaccines, patient was a healthy young woman, who lived a very independent life,. and was preparing to serve a mission for her church and attend college. Unfortunately, patient was unable to serve her mission, and has had to resort to online school. Patient has become completely dependent on her mother for transportation, cooking, cleaning, and shopping.and is no longer able to enjoy being outside due to her intolerance to the heat. All of which she was able to do on her own prior to the vaccines. Patient has to take a minimum of a 2 hour nap daily due to extreme fatigue. Patient continues to suffer from these symptoms which have increased within the last 2-3 weeks (November/December 2023). Patient has tried and failed fludrocortisone and Midodrine due to drug allergies. Dr., Interventional Cardiologist,  has recommend she be treated at the Autonomic Dysfunction Clinic, who has developed a treatment for this condition. However, due to insurance deficiencies with no out of network coverage, and denial of preauthorization from insurance, patient continues to go without treatment and is beginning to decline more rapidly from her symptoms. There are no in-network providers who are treating for Covid-19 Vaccine injuries. Clinic requires a $5,000 cash deposit to begin treatment, money I do not have access to. I continue to appeal insurance, and thus far, have been unsuccessful.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test negative, Syncope, Tachycardia, Temperature intolerance
Clinical narrative: Extreme fatigue, dizziness, syncope, headache, joint pain, heart palpitations, tachycardia, fluctuating heart rate, GI upset, shortness of breath with exertion, intolerance to heat, visual disturbance and muscle weakness impacting all activities of daily life, worsening after the 3rd dose of the Pfizer BioNTech received on 12/21/2021 with lot# FL3198. Prior to the Covid-19 vaccines, patient was a healthy young woman, who lived a very independent life,. and was preparing to serve a mission for her church and attend college. Unfortunately, patient was unable to serve her mission, and has had to resort to online school. Patient has become completely dependent on her mother for transportation, cooking, cleaning, and shopping.and is no longer able to enjoy being outside due to her intolerance to the heat. All of which she was able to do on her own prior to the vaccines. Patient has to take a minimum of a 2 hour nap daily due to extreme fatigue. Patient continues to suffer from these symptoms which have increased within the last 2-3 weeks (November/December 2023). Patient has tried and failed fludrocortisone and Midodrine due to drug allergies. Dr., Interventional Cardiologist,  has recommend she be treated at the Autonomic Dysfunction Clinic, who has developed a treatment for this condition. However, due to insurance deficiencies with no out of network coverage, and denial of preauthorization from insurance, patient continues to go without treatment and is beginning to decline more rapidly from her symptoms. There are no in-network providers who are treating for Covid-19 Vaccine injuries. Clinic requires a $5,000 cash deposit to begin treatment, money I do not have access to. I continue to appeal insurance, and thus far, have been unsuccessful.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound thyroid normal, Visual impairment
Clinical narrative: Extreme fatigue, dizziness, syncope, headache, joint pain, heart palpitations, tachycardia, fluctuating heart rate, GI upset, shortness of breath with exertion, intolerance to heat, visual disturbance and muscle weakness impacting all activities of daily life, worsening after the 3rd dose of the Pfizer BioNTech received on 12/21/2021 with lot# FL3198. Prior to the Covid-19 vaccines, patient was a healthy young woman, who lived a very independent life,. and was preparing to serve a mission for her church and attend college. Unfortunately, patient was unable to serve her mission, and has had to resort to online school. Patient has become completely dependent on her mother for transportation, cooking, cleaning, and shopping.and is no longer able to enjoy being outside due to her intolerance to the heat. All of which she was able to do on her own prior to the vaccines. Patient has to take a minimum of a 2 hour nap daily due to extreme fatigue. Patient continues to suffer from these symptoms which have increased within the last 2-3 weeks (November/December 2023). Patient has tried and failed fludrocortisone and Midodrine due to drug allergies. Dr., Interventional Cardiologist,  has recommend she be treated at the Autonomic Dysfunction Clinic, who has developed a treatment for this condition. However, due to insurance deficiencies with no out of network coverage, and denial of preauthorization from insurance, patient continues to go without treatment and is beginning to decline more rapidly from her symptoms. There are no in-network providers who are treating for Covid-19 Vaccine injuries. Clinic requires a $5,000 cash deposit to begin treatment, money I do not have access to. I continue to appeal insurance, and thus far, have been unsuccessful.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray abnormal, Cough, Eye discharge, Eye inflammation, Myalgia
Clinical narrative: I contacted the CDC a couple of days ago, after my wife (74) had the GSK Arexvy RSV vaccine at a local Pharmacy and seemed to contract the RSV virus.  Your organization basically said that the RSV vaccine is made up of an inactive virus that cannot cause the virus, but something occurred that seemed to mimic the same virus that I contracted last summer.  She appeared to be completely healthy at the time she asked for the RSV vaccine on December 8th, and due to the fact that I (75 at the time) had actually contracted the virus in July from a relative that got it from his grandchild, and had gone through a two week battle that lingered into a third week, I recommended that she get the shot to prevent her from going through what I had experienced.  The first night she experienced a sore shoulder muscle and a temp of 98.8 degrees, but for the next six nights experienced horrendous coughing, phlegm, and fever (up to 102.1 at one point).  In addition, her one eye, and then both eyes, became inflamed with mucus.  We had no other choice but to go to Urgent Care today, December 15th, to find out what was happening.  After an Xray, it was confirmed that she now has pneumonia and was given a shot, was put on antibiotics, and had drops prescribed for her eyes.  We sincerely believe that the virus, that's not supposed to have any active virus, gave her the condition that she is suffering from.  I confirmed with the pharmacist (and she showed me the vaccine box) that the vaccine was manufactured by GlaxoSmithKline (GSK).  We really think that you need to know what we experienced.  When you get a vaccination, we don't expect that we are going to get the illness you are trying to prevent!
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Pneumonia, Productive cough, Pyrexia
Clinical narrative: I contacted the CDC a couple of days ago, after my wife (74) had the GSK Arexvy RSV vaccine at a local Pharmacy and seemed to contract the RSV virus.  Your organization basically said that the RSV vaccine is made up of an inactive virus that cannot cause the virus, but something occurred that seemed to mimic the same virus that I contracted last summer.  She appeared to be completely healthy at the time she asked for the RSV vaccine on December 8th, and due to the fact that I (75 at the time) had actually contracted the virus in July from a relative that got it from his grandchild, and had gone through a two week battle that lingered into a third week, I recommended that she get the shot to prevent her from going through what I had experienced.  The first night she experienced a sore shoulder muscle and a temp of 98.8 degrees, but for the next six nights experienced horrendous coughing, phlegm, and fever (up to 102.1 at one point).  In addition, her one eye, and then both eyes, became inflamed with mucus.  We had no other choice but to go to Urgent Care today, December 15th, to find out what was happening.  After an Xray, it was confirmed that she now has pneumonia and was given a shot, was put on antibiotics, and had drops prescribed for her eyes.  We sincerely believe that the virus, that's not supposed to have any active virus, gave her the condition that she is suffering from.  I confirmed with the pharmacist (and she showed me the vaccine box) that the vaccine was manufactured by GlaxoSmithKline (GSK).  We really think that you need to know what we experienced.  When you get a vaccination, we don't expect that we are going to get the illness you are trying to prevent!
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: left arm pain, numbness, tingling for a month post injection
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypoxia
Clinical narrative: Hospitalization for COVID-19 infection with hypoxia on dates 12/7/2023- 12/13/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, COVID-19, Chemotherapy, Cholangiocarcinoma
Clinical narrative: Hospitalization for COVID-19, acute on chronic abdominal pain (in the process of chemotherapy treatment for cholangiocarcinoma) on dates 12/8/2023- 12/11/2023.  Treated with supportive breathing treatment.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pyrexia, Vomiting
Clinical narrative: Overnight (Saturday to Sunday) she threw up 4 times starting at 11PM. On Sunday she woke up with a 100.3 degree fever. Over the course of the day it went up to 102. Used ibuprofen (Motrin) to bring fever down to 99. She threw up twice more in the afternoon. This morning she doesn't have a fever but is still weak and nauseaus.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm, Atrial fibrillation, COVID-19, Chronic lymphocytic leukaemia, Goitre
Clinical narrative: Hospitalization for new-onset Atrial fibrillation with RVR, CLL without symptoms, 4.5cm ascending aortic aneurysm, COVID-19 minimal symptoms, multinodular goiter on dates 12/11/2023- 12/12/2023. Treated with  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came to the clinic for her vaccine appointment (Covid19 + flu) along with daughter (4 years old) and husband, both who required the same vaccines.  Vaccines were already pulled by colleague in two different trays- one for Covid-19 and the other for flu. All patients walked in the treatment room and while talking to patient, nurse (myself) administered one dose of covid-19 on the left arm and a second dose of covid-19 on the right arm (both Pfizer Comirnaty adult dose)  Provider was briefed on the situation as soon as error was discovered (right after vaccination) and patient was told about the error. Patient was calmed and handled the information well, stating "these errors happen all the time"  Patient was monitored at the clinic for 1hr after administration and did not show any immediate adverse effects. Patient educated about side effects of vaccine such as sore arm, fever, body aches and advised to take ibuprofen or tylenol per package instructions. She was also given the duty phone number to contact in case she presents any concerning symptoms such as chest pain, SOB, palpitations and dizziness,  Patient was awake and alert, in no distress at the time she was discharged from the unit.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient received adult dose of Havrix. No known adverse signs/symptoms occurred.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Rapid onset of wheezing (within 15 minutes), cough, shortness of breath. Epinephrine and albuterol given in office prior to EMS arrival. Rapid improvement with epinephrine and albuterol with stable condition for transport to emergency room. Child had observation and was back to baseline the following day.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Accelerated hypertension, Acute kidney injury, COVID-19, Hypercalcaemia, Hyperglycaemia
Clinical narrative: Hospitalization for acute renal failure, COVID-19 infection, elevated troponin level, accelerated hypertension, hyperglycemia, hypercalcemia, paroxysmal SVT, chronic anticoagulation, physical deconditioning on dates 12/14/2023- 12/17/2023. Treated with vitamin C 500 mg PO daily, zinc 50 mg PO daily.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Physical deconditioning, Supraventricular tachycardia, Troponin increased
Clinical narrative: Hospitalization for acute renal failure, COVID-19 infection, elevated troponin level, accelerated hypertension, hyperglycemia, hypercalcemia, paroxysmal SVT, chronic anticoagulation, physical deconditioning on dates 12/14/2023- 12/17/2023. Treated with vitamin C 500 mg PO daily, zinc 50 mg PO daily.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Arthritis, Blood test, Condition aggravated, Contusion
Clinical narrative: He got his vaccine, started out with very severe pain in the left shoulder, arthritic type pain in the shoulder joint and in his neck joint as well, extremely severe.  He felt he had slipped a disc or broken one late at night and hurt so bad that he felt that he could not drive to go to the ER.  It moved down his body during the night, moved to hip joint, knee joint and muscles, tendons and ligaments in his foot.  He has an IT band problem, and the IT band started contracting and would do so intermittently to the point that it was too painful to stay in the bed.  He still cannot sit down for very long as if he bends his left leg at all it starts really really hurting, and has not been able to sleep even with all the medicines described.  This went on for several days, and had an old prescription for opioids and read that after 4 days it would go away and it did not.  It was especially bad at night.  The only way he feels comfortable with his knee, foot and leg if he walks for about an hour and gets some calming effect but pain has not been gone.  This has been going on for several weeks, has worn him out as he cannot sleep.   He has not been able to go to his fitness classes which helps with his chronic pain, and not been able to socialize due to the pain.  He is still having pain now.  His doctor is referring him to a rheumatologist, but that may take a while.  After the initial 4 days he decided to go to the ER as he ran out of his prescription of medicine that he had.  He went to minor ER and gave him a shot of Toradol and muscle relaxers.  He went to another ER and they only had a NP on call.  He then went to second ER they felt that he was drug seeking, as he was not writhing in pain they felt he was faking it.   He then went to his PCP and he told him that he basically has a substance abuse problem, and changed physicians.  She had seen his reactions as one of the nurses had the same reaction and she prescribed Tylenol #3, which has not taken away the pain, Meloxicam, Tizanidine 4 mg every 6-8 hours, Pregabalin and upped to 150 mg.  The pain is receding somewhat, somewhat in his leg, but still very severe in his leg, shin and the top of his left foot.   It is in the area of the neuroma, but not too bad.  It has also caused what feels like holes or tears in his muscles which when he touches them are excruciating in the front of his leg quad muscles feels like a sore place, also his lower left calf there is a pretty bad place and behind his left knee.  His whole shin under the left shin is bruised to the point that they had turned purple.  The leg is still somewhat red.  He never had problems in the arm itself.    He has had problems with his leg prior to the vaccine, IT band pain due to severe sciatica, but the vaccine exacerbated the pain and created an acute severe arthritis.    It is not as severe right now, but is only about to get 4-5 hours of sleep max due to the pain.  He is not able to get out and about, having depression due to being trapped in his house due to the discomfort and pain.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Depression, Discomfort, Erythema, Fatigue, Housebound
Clinical narrative: He got his vaccine, started out with very severe pain in the left shoulder, arthritic type pain in the shoulder joint and in his neck joint as well, extremely severe.  He felt he had slipped a disc or broken one late at night and hurt so bad that he felt that he could not drive to go to the ER.  It moved down his body during the night, moved to hip joint, knee joint and muscles, tendons and ligaments in his foot.  He has an IT band problem, and the IT band started contracting and would do so intermittently to the point that it was too painful to stay in the bed.  He still cannot sit down for very long as if he bends his left leg at all it starts really really hurting, and has not been able to sleep even with all the medicines described.  This went on for several days, and had an old prescription for opioids and read that after 4 days it would go away and it did not.  It was especially bad at night.  The only way he feels comfortable with his knee, foot and leg if he walks for about an hour and gets some calming effect but pain has not been gone.  This has been going on for several weeks, has worn him out as he cannot sleep.   He has not been able to go to his fitness classes which helps with his chronic pain, and not been able to socialize due to the pain.  He is still having pain now.  His doctor is referring him to a rheumatologist, but that may take a while.  After the initial 4 days he decided to go to the ER as he ran out of his prescription of medicine that he had.  He went to minor ER and gave him a shot of Toradol and muscle relaxers.  He went to another ER and they only had a NP on call.  He then went to second ER they felt that he was drug seeking, as he was not writhing in pain they felt he was faking it.   He then went to his PCP and he told him that he basically has a substance abuse problem, and changed physicians.  She had seen his reactions as one of the nurses had the same reaction and she prescribed Tylenol #3, which has not taken away the pain, Meloxicam, Tizanidine 4 mg every 6-8 hours, Pregabalin and upped to 150 mg.  The pain is receding somewhat, somewhat in his leg, but still very severe in his leg, shin and the top of his left foot.   It is in the area of the neuroma, but not too bad.  It has also caused what feels like holes or tears in his muscles which when he touches them are excruciating in the front of his leg quad muscles feels like a sore place, also his lower left calf there is a pretty bad place and behind his left knee.  His whole shin under the left shin is bruised to the point that they had turned purple.  The leg is still somewhat red.  He never had problems in the arm itself.    He has had problems with his leg prior to the vaccine, IT band pain due to severe sciatica, but the vaccine exacerbated the pain and created an acute severe arthritis.    It is not as severe right now, but is only about to get 4-5 hours of sleep max due to the pain.  He is not able to get out and about, having depression due to being trapped in his house due to the discomfort and pain.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia, Neck pain, Neuroma, Pain, Pain in extremity
Clinical narrative: He got his vaccine, started out with very severe pain in the left shoulder, arthritic type pain in the shoulder joint and in his neck joint as well, extremely severe.  He felt he had slipped a disc or broken one late at night and hurt so bad that he felt that he could not drive to go to the ER.  It moved down his body during the night, moved to hip joint, knee joint and muscles, tendons and ligaments in his foot.  He has an IT band problem, and the IT band started contracting and would do so intermittently to the point that it was too painful to stay in the bed.  He still cannot sit down for very long as if he bends his left leg at all it starts really really hurting, and has not been able to sleep even with all the medicines described.  This went on for several days, and had an old prescription for opioids and read that after 4 days it would go away and it did not.  It was especially bad at night.  The only way he feels comfortable with his knee, foot and leg if he walks for about an hour and gets some calming effect but pain has not been gone.  This has been going on for several weeks, has worn him out as he cannot sleep.   He has not been able to go to his fitness classes which helps with his chronic pain, and not been able to socialize due to the pain.  He is still having pain now.  His doctor is referring him to a rheumatologist, but that may take a while.  After the initial 4 days he decided to go to the ER as he ran out of his prescription of medicine that he had.  He went to minor ER and gave him a shot of Toradol and muscle relaxers.  He went to another ER and they only had a NP on call.  He then went to second ER they felt that he was drug seeking, as he was not writhing in pain they felt he was faking it.   He then went to his PCP and he told him that he basically has a substance abuse problem, and changed physicians.  She had seen his reactions as one of the nurses had the same reaction and she prescribed Tylenol #3, which has not taken away the pain, Meloxicam, Tizanidine 4 mg every 6-8 hours, Pregabalin and upped to 150 mg.  The pain is receding somewhat, somewhat in his leg, but still very severe in his leg, shin and the top of his left foot.   It is in the area of the neuroma, but not too bad.  It has also caused what feels like holes or tears in his muscles which when he touches them are excruciating in the front of his leg quad muscles feels like a sore place, also his lower left calf there is a pretty bad place and behind his left knee.  His whole shin under the left shin is bruised to the point that they had turned purple.  The leg is still somewhat red.  He never had problems in the arm itself.    He has had problems with his leg prior to the vaccine, IT band pain due to severe sciatica, but the vaccine exacerbated the pain and created an acute severe arthritis.    It is not as severe right now, but is only about to get 4-5 hours of sleep max due to the pain.  He is not able to get out and about, having depression due to being trapped in his house due to the discomfort and pain.