chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Moderna Bivalent Booster 0.25mcg was given which was wrong dosage, was to be given 0.5mcg.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Pt had red, hot, and itchy arm after shingrix immunization
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Dehydration, Diarrhoea
Clinical narrative: I had diarrhea, chills, headache, nausea, joint pain, and fever. I went to the doctor, and I tested positive for COVID-19. They told me if I wasn't feeling better to come back in. I wasn't feeling better, so I went back to the doctor. They gave me fluids because I was dehydrated. They checked my lungs, and they were clear. Now I feel so much better, but I am tired
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had diarrhea, chills, headache, nausea, joint pain, and fever. I went to the doctor, and I tested positive for COVID-19. They told me if I wasn't feeling better to come back in. I wasn't feeling better, so I went back to the doctor. They gave me fluids because I was dehydrated. They checked my lungs, and they were clear. Now I feel so much better, but I am tired
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Mammogram abnormal, SARS-CoV-2 test negative
Clinical narrative: Before getting my 4th booster shot I received a 2nd dose of the shingle  vaccine on  12/01/2022.  I received my 4th Moderna Bivalent Booster on 10/10/2022. On 09/19/2022 I visited my doctor for a yearly check-up. She referred me to get my mammograms  done. I scheduled my  Screening Mammograms  on  12/05/2022 at 06:30pm. When  I got my Screening Mammograms done they notified me that my first Mammograms was suspicious. They advised me to reschedule a second  Diagnostic Mammograms  and an Ultra Sound so I scheduled it for 12/23/2022.  When the second Mammograms were done . They gave me the results right way and  told that my Mammograms were normal . I didn't need to get the Ultra Sound done anymore.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was requesting a bi-valent vaccine. Due to look alike vials, the patient received a mono-valent vaccine. Patient has been notified. No adverse effects occurred.
Age: 74.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: I was given the Pfizer Covid Bival (12YUP) EUA shot although I have never received the 2 dose premier shots. The appointment email clearly said I was scheduled to receive the Covid-19 (Pfizer - 1st dose)
Age: 74.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: I was given the Pfizer Covid Bival (12YUP) EUA shot although I have never received the 2 dose premier shots. The appointment email clearly said I was scheduled to receive the Covid-19 (Pfizer - 1st dose)
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Testicular pain, Testicular swelling
Clinical narrative: The morning after receiving the Johnson & Johnson Covid Vaccine I began to have dull pain in my testicles.  Not thinking much of it, I went along with my day only for the pain to continue into the evening.  That night when I went to take a shower  i noticed that my testicles were not only painful but slightly swollen. The pain and swelling continued until the third day in which the pain slightly decreased along with some of the swelling.  After about 5-7 days the pain was still periodically there (dull, sore pain) and the swelling was 90% gone. The issue continued for a few months until I visited my Primary Physician who wasn't sure about the issue but gave me an Antibiotic. The Antibiotic didn't change or fix the problem and the issue exists to this day.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Erythema, Pruritus, Rash papular
Clinical narrative: redness, erythema, raised itchy, grew over the span of two days in the upper arm region, required ibuprofen to help with discomfort
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN 0.25 ML INJECTION. APPROPRIATE DOSE WOULD HAVE BEEN 0.5 ML INJECTION. THE 0.25 ML INJECTION IS INDICATED FOR PATIENTS 6-12 YEARS OF AGE.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: PATIENT RECEIVED 0.25 ML INJECTION. APPROPRIATE DOSE WOULD HAVE BEEN 0.5 ML INJECTION. THE 0.25 ML INJECTION IS INDICATED FOR PATIENTS BETWEEN 6 AND 12 YEARS OF AGE. PATIENT HAD NOT ADVERSE REACTION TO VACCINE.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, Pyrexia, Thrombosis, Upper respiratory tract infection
Clinical narrative: On 9/19/2021 had sob and fever.  Diagnosed with uri. Then 9/22/2021 had sob and diagnosed with saddle PE and right leg blood clot.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient administered a flublok, that is recommeneded for patients 18 years or more.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Confirmed positive covid after vaccination
Age: 73.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Syringe issue
Clinical narrative: Upon administering Shingrix with a Vantage point syringe the needle came off the syringe and the vaccine contents did not penetrate the patients's arm.  The patient was revaccinated.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Fatigue, Headache, Injection site nodule, Injection site pain
Clinical narrative: Soreness at injection site. After about 12 hours, a small red  rash began to appear. Body aches, exhaustion, headache, loss of appetite, nausea. 24 hours later, the red rash extended further and a lump formed. Very sore to the touch and difficult to lift arm.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site reaction, Mobility decreased, Nausea, Pain, Rash
Clinical narrative: Soreness at injection site. After about 12 hours, a small red  rash began to appear. Body aches, exhaustion, headache, loss of appetite, nausea. 24 hours later, the red rash extended further and a lump formed. Very sore to the touch and difficult to lift arm.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash erythematous
Clinical narrative: Soreness at injection site. After about 12 hours, a small red  rash began to appear. Body aches, exhaustion, headache, loss of appetite, nausea. 24 hours later, the red rash extended further and a lump formed. Very sore to the touch and difficult to lift arm.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocardis
Age: 15.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red swelling at site of covid vaccine Covid vaccine given in lower portion of arm and flu vaccine given in upper portion of arm
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Epistaxis
Clinical narrative: Persistent nose bleed
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Laboratory test, Mobility decreased, Nausea
Clinical narrative: The date on the vaccination card is 2/5/22, not 2/9/22 as previously stated.  I started having fever by 9pm and was in bed unable to get up except to toilet for 24 hours, then nauseous for 24 hours then the coughing and wheezing started. I have been coughing and wheezing for 11 months.  I have been to 2 different providers at a local minute clinic who refused to treat me and my primary care refused to treat me.  I did  not pursue the pulmonologist., but it has been difficult to sleep at times because the wheezing keeps me awake.  I have taken guafenisen otc and it has helped a little,  An NP from another location prescribed a steroid pack which helped while I was on it but symptoms returned when it was completed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Wheezing
Clinical narrative: The date on the vaccination card is 2/5/22, not 2/9/22 as previously stated.  I started having fever by 9pm and was in bed unable to get up except to toilet for 24 hours, then nauseous for 24 hours then the coughing and wheezing started. I have been coughing and wheezing for 11 months.  I have been to 2 different providers at a local minute clinic who refused to treat me and my primary care refused to treat me.  I did  not pursue the pulmonologist., but it has been difficult to sleep at times because the wheezing keeps me awake.  I have taken guafenisen otc and it has helped a little,  An NP from another location prescribed a steroid pack which helped while I was on it but symptoms returned when it was completed.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Asthenia, Chest pain, Dizziness
Clinical narrative: Chest pain began the evening of June 18th 2021. Chest pains continue to this day. I began having daily debilitating headaches that continue to this day. Difficulty breathing that comes and goes. Muscle spasms in legs, arms, and face.  Severe anxiety. GI issues such as bloating, cramping, blood and mucus in stool. Daily dizziness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haematochezia, Headache, Laboratory test normal, Mucous stools
Clinical narrative: Chest pain began the evening of June 18th 2021. Chest pains continue to this day. I began having daily debilitating headaches that continue to this day. Difficulty breathing that comes and goes. Muscle spasms in legs, arms, and face.  Severe anxiety. GI issues such as bloating, cramping, blood and mucus in stool. Daily dizziness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Chest pain began the evening of June 18th 2021. Chest pains continue to this day. I began having daily debilitating headaches that continue to this day. Difficulty breathing that comes and goes. Muscle spasms in legs, arms, and face.  Severe anxiety. GI issues such as bloating, cramping, blood and mucus in stool. Daily dizziness
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder pain developed after the vaccine was administered. Pt associates the shoulder pain with receiving the vaccine
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Death, Dyspnoea, Endotracheal intubation, Laboratory test abnormal
Clinical narrative: shortness of breath called 911 around noon admitted to ER around 1pm tests in ER determined Bilateral Pulmonary Embolism Pushed meds to help dissolve clots Intubated to help breath as meds were pushed Passed away before being transferred from ER to ICU around 11:30pm same day
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: shortness of breath called 911 around noon admitted to ER around 1pm tests in ER determined Bilateral Pulmonary Embolism Pushed meds to help dissolve clots Intubated to help breath as meds were pushed Passed away before being transferred from ER to ICU around 11:30pm same day
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Condition aggravated, Insomnia, Neuralgia, Neuropathy peripheral
Clinical narrative: A few weeks after vaccine - severe burning mouth and tongue and oral sores.   Also tinnitus worsened - tinnitus first occurred after 2nd covid vaccine.   Increased neuropathy in extremities.  New buzzing/nerve pain in chest and heart palpitations  Insomnia
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oral discomfort, Palpitations, Stomatitis, Tinnitus, Tongue discomfort
Clinical narrative: A few weeks after vaccine - severe burning mouth and tongue and oral sores.   Also tinnitus worsened - tinnitus first occurred after 2nd covid vaccine.   Increased neuropathy in extremities.  New buzzing/nerve pain in chest and heart palpitations  Insomnia
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vibratory sense increased
Clinical narrative: A few weeks after vaccine - severe burning mouth and tongue and oral sores.   Also tinnitus worsened - tinnitus first occurred after 2nd covid vaccine.   Increased neuropathy in extremities.  New buzzing/nerve pain in chest and heart palpitations  Insomnia
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Non-known Pt received undiluted vaccine
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Rashes all over the body like hives. Slight fever in the morning.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dermatitis allergic, Pruritus, Sensitive skin
Clinical narrative: 11 days after getting the shot, I experienced full-body allergic dermatitis. My skin became very itchy and sensitive to touch, especially around the neck and head. After three days with no improvement, I sought care from my doctor through an e-visit. They prescribed five days of Prednisone and recommended an over-the-counter antihistamine, which I have been taking twice a day for the past week. The full-body itching is less severe but my skin is still extremely sensitive.
Age: 2.17
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Did not give Bivalent as the 3rd dose gave regular as 3rd dose. -No reactions
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Monovalent for the third dose instead of Bivalent
Age: 3.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent for third dose instead of Bivalent
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Monovalent for the third dose instead of Bivalent
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Did not give Bivalent as the 3rd dose gave regular under5. -No reactions
Age: 2.33
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Monovalent for third dose instead of Bivalent
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Monovalent for the third dose instead of Bivalent
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.17
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Monovalent for the third dose instead of Bivalent
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Monovalent for third dose instead of Bivalent
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Monovalent for the third dose instead of Bivalent
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bivalent not given as the 3rd dose. gave regular under 5 - no reactions
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Did not give Bivalent as the 3rd dose. gave regular under 5 dose -no reactions
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse events, reactions, signs Bivalent dose not giving for 3rd dose in series.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bronchitis, Chills, Cough, Productive cough
Clinical narrative: Coughing, phlegm, chills but no fever. Internist diagnosed as bronchitis, prescribed Azithromycin antibiotic, Z-pack 5 days, starting 12/29/22
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: DID NOT GIVE BIVALENT AS THE 3RD dose gave regular as 3rd dose  NO REACTIONS.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: DID NOT GIVE BIVALENT AS 3RD DOSE gave regular as 3rd Dose. NO REACTIONS
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Patient was siting down and nurse noticed that she had her head down. Another nurse called for Dr to check patient out. Patient passed out for couple of seconds. Pt vitals was monitored. Patient was given water. After a few minutes patient was ok and walked out of the office with her partner.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Cough, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Myalgia & Fever Narrative:  Reports recieved Bivalent booster of pfizer on 1/5/23 at medical office, began to experience fever, cough, myalgia fatigue back pain swelling in axillary lymph nodes within 24 hrs of recieving booster. After original Pfizer covid vaccine series, states had 1 week of similar symptoms. Home covid antigen testing negative. Patient is in communication with primary care provider as well.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Myalgia & Fever Narrative:  Reports recieved Bivalent booster of pfizer on 1/5/23 at medical office, began to experience fever, cough, myalgia fatigue back pain swelling in axillary lymph nodes within 24 hrs of recieving booster. After original Pfizer covid vaccine series, states had 1 week of similar symptoms. Home covid antigen testing negative. Patient is in communication with primary care provider as well.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Electrocardiogram normal, Grip strength decreased, Hypoaesthesia
Clinical narrative: Angina numbness and tingling in fingers, weakness in r hand, dropping items Narrative:  On 1/3/23 (over 1 year since booster recieved) reports experienced chest pain on 11/9/21 within 5 hrs of recieving covid booster. These symptoms were just reported 1/3/23. States visited ED on 11/9/21, normal ekg and labs, including inflammatory markers drawn, findings normal. She was discharged to home. Also reporting since the covid booster tingling and numbness in hands, weakness of grip dropping items with right hand. Is followed by pcp, and a nerve conduction study is pending with her pcp. Offered occupational medicine visit for possible vaccine reaction, employee declines this.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker test, Laboratory test normal, Muscular weakness, Paraesthesia
Clinical narrative: Angina numbness and tingling in fingers, weakness in r hand, dropping items Narrative:  On 1/3/23 (over 1 year since booster recieved) reports experienced chest pain on 11/9/21 within 5 hrs of recieving covid booster. These symptoms were just reported 1/3/23. States visited ED on 11/9/21, normal ekg and labs, including inflammatory markers drawn, findings normal. She was discharged to home. Also reporting since the covid booster tingling and numbness in hands, weakness of grip dropping items with right hand. Is followed by pcp, and a nerve conduction study is pending with her pcp. Offered occupational medicine visit for possible vaccine reaction, employee declines this.
Sex: F
Vaccine: FLUX
Symptoms: Product storage error
Clinical narrative: Narrative: Issue Title: Frozen Influenza Vaccine Date of Report: October 14, 2022. (October 26, 2022) Brief Statement of Issue and Status: On October 13, 2022, At the completion of the vaccination clinic conducted throughout the day of October 13, the pharmacy Chief, who received the remaining flu vaccines noticed that some (39) of the vaccines were frozen and / or partially frozen. The pharmacy Chief questioned the nurse who returned the vaccine and nurse verified that yes throughout the day it was noticed that some of the vaccines were frozen or partially frozen. The pharmacy Chief confirmed  that per the manufacturers recommendation the flu vaccine is to be discarded if frozen. Actions, Progress and Resolution Date: On, October 14, 2022, at 10:00 the Flu Workgroup along with Risk management, to include VISN and National Risk Management met to discuss the event. During the meeting it was found that approximately 182 patients who received flu vaccinations on 10/12/2022 and 10/13/2022 may have received either a previously frozen or partially frozen flu vaccine. The Assistant Chief of Pharmacy contacted the manufacture (Seqiris) of the flu vaccine, who confirmed that if the flu vaccine becomes frozen it should be discarded. The flu workgroup has rectified the system issues of how and why the flu vaccines became frozen and have taken preventative measures to ensure this does not occur again on campus or at any of our facilities. A Root Cause Analysis (RCA) will be chartered to review system issues. A Safety Forum will be conducted related to this event. This will potentially lead to a large-scale disclosure. October 26, 2022 - Update: This incident was reviewed by the Facility Central Office Clinical Episode Review Team (CERT) on October 14, 2022, which determined that large-scale disclosure is not indicated at this time. As such, all 182 patients (now confirmed) will be called to perform clinical disclosure, discussing the concerns of the efficacy of the vaccination, risk/benefits, and recommendations for additional vaccination. Patients unable to be reached after three call attempts will receive a certified letter for disclosure. The clinical disclosure will be documented within records. The Root Cause Analysis found the cause to be vaccines lying directly on the ice packs inside the cooler. This has not been corrected by placing bubble wrap between the vaccine and the ice pack to prevent the vaccine from freezing. A temperature log has been developed to ensure the coolers remain within the appropriate range.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Gait inability, Influenza virus test negative, Pain
Clinical narrative: Narrative:  3/172022 ED visit: Pt presented to agency ED with c/o general weakness since yesterday. Pt said he got COVID vaccine yesterday. Denies SOB. Has some cough, body aches at home. He states he woke up with 104 temp today. 3/24/22 - Pt states he is doing okay but says last Wednesday (3/16) he had his COVID booster and the next day he woke up and "felt paralyzed" as he says he could not move. He went to a community ED but after being sent home, he decided to come to the facility. He says a few hours later he felt better and was allowed to be discharged. He says he was having fever and could not walk so he tried crawling but skinned his legs in the process. He is much better today and has no complaints.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Pyrexia, SARS-CoV-2 test negative, Skin laceration
Clinical narrative: Narrative:  3/172022 ED visit: Pt presented to agency ED with c/o general weakness since yesterday. Pt said he got COVID vaccine yesterday. Denies SOB. Has some cough, body aches at home. He states he woke up with 104 temp today. 3/24/22 - Pt states he is doing okay but says last Wednesday (3/16) he had his COVID booster and the next day he woke up and "felt paralyzed" as he says he could not move. He went to a community ED but after being sent home, he decided to come to the facility. He says a few hours later he felt better and was allowed to be discharged. He says he was having fever and could not walk so he tried crawling but skinned his legs in the process. He is much better today and has no complaints.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Narrative: Patient received first dose of Moderna COVID vaccine 03/10/2021 and second dose on 04/12/2021. No documented reactions until patient offered booster in 05/2022 in which patient declined booster and reported that he did not tolerate the vaccine due to "nights sweats". Time and date of "night sweats" not specified in chart.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Confusional state, Headache, Injected limb mobility decreased, Musculoskeletal stiffness
Clinical narrative: Confusion, Headache, Arthralgia, Transient Aphasia Narrative:  Employee reports HA started w/in 30 min of COVID bivalent booster vaccine progressively got worse with transient aphasia morning of 01/07/2023 confused too major effort to say the words "Good morning" thoughts and words from mouth did not match was talking "nonsensical", reports one episode of transient aphasia, headache continued till approx 10am 01/08/2023. +Stiff neck onset several hours after vaccine on 01/05/2023 improved but still present as of 01/09/2023. +left arm sore/pain woke employee up at 1am on 01/06/2023 progressively got worse to the point unable to lift arm and resolved on 01/07/2023.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Transient aphasia
Clinical narrative: Confusion, Headache, Arthralgia, Transient Aphasia Narrative:  Employee reports HA started w/in 30 min of COVID bivalent booster vaccine progressively got worse with transient aphasia morning of 01/07/2023 confused too major effort to say the words "Good morning" thoughts and words from mouth did not match was talking "nonsensical", reports one episode of transient aphasia, headache continued till approx 10am 01/08/2023. +Stiff neck onset several hours after vaccine on 01/05/2023 improved but still present as of 01/09/2023. +left arm sore/pain woke employee up at 1am on 01/06/2023 progressively got worse to the point unable to lift arm and resolved on 01/07/2023.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Ear discomfort, Fatigue, Headache, Pain
Clinical narrative: Narrative:  Patient received J&J vaccine on 08/31/2021 at 11am per documentation. Patient reports headache and body aches after administration. Patient then reports that evening at 930pm he "got the tremors and froze up", denied loss of consciousness or fall. Patient reported "having no control of his body for 45 seconds to a minute" referred to episode as "mini seizure" with no PMH of seizures. Patient reported to urgent care on 09/02/2021 for evaluation of "seizure". At that time also reported "increased pressure in his ears, like they were going to explode", chest pain mid sternal, and fatigue. Provider concluded that episode did not align with a seizure despite patient's belief of having a seizure despite no PMH of seizures. Patient discharged to follow up with PCP who later entered allergy as "seizure" in chart. Of note, patient has multiple MH diagnosis and history of hyperbolic narrative.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Tremor
Clinical narrative: Narrative:  Patient received J&J vaccine on 08/31/2021 at 11am per documentation. Patient reports headache and body aches after administration. Patient then reports that evening at 930pm he "got the tremors and froze up", denied loss of consciousness or fall. Patient reported "having no control of his body for 45 seconds to a minute" referred to episode as "mini seizure" with no PMH of seizures. Patient reported to urgent care on 09/02/2021 for evaluation of "seizure". At that time also reported "increased pressure in his ears, like they were going to explode", chest pain mid sternal, and fatigue. Provider concluded that episode did not align with a seizure despite patient's belief of having a seizure despite no PMH of seizures. Patient discharged to follow up with PCP who later entered allergy as "seizure" in chart. Of note, patient has multiple MH diagnosis and history of hyperbolic narrative.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Diffuse cutaneous mastocytosis
Clinical narrative: She had covid vax in 10/21; WBC was normal in 7/21 and had dropped to 3.3 in 3/22. Colon cancer diagnosed in October/2021 by Colon biopsy and Cutaneous Mastocytosis in December/2022 by skin biopsy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Anxiety, Chest X-ray abnormal, Chest pain, Deep vein thrombosis
Clinical narrative: THE MORNING AFTER VACCINE ADMINISTRATION, DUE TO SEVERE CHEST PAIN, PATIENT WAS TAKEN TO EMERGENCY DEPARTMENT AT HOSPITAL. PATIENT WAS DIAGNOSED WITH SUSPECTED PULMONARY EMBOLISM (PE), AND DVT WAS CONFIRMED USING SONOGRAM IN RIGHT LEG FEMORAL REGION. PATIENT WAS THEN ADMITTED TO THE ICU FOR FURTHER MONITORING. The first dose of the vaccine (Moderna 001C21A) was given on 23 April 2021. The patient had a sore upper arm and no other significant observations. She had no other pain, issues, or health concerns of any kind. It was the second trimester in her pregnancy so walking and moderate exercise did not lead to any pain or shortness of breath.   The second dose of the vaccine (Moderna 033C21A) was administered on 2 May 2021. That afternoon, she began feeling progressively tired and uncomfortable. During the night she was feverish, anxious, could not sleep, and began feeling unwell. The next morning she could not move around normally, was becoming short of breath, and discovered a sharp pain in her right leg when she put weight on it that felt like a string being pulled tight. Around 8:00 am, she began having chest pain. By 9:30 AM she had severe chest pain and was having difficulty breathing. She called her husband to report her situation, and he immediately left work to take her to the emergency room because she had to pause in the middle of sentences to catch her breath. He was almost an hour drive away and instructed her to call an ambulance if the difficulty breathing became any worse. Luckily, her difficulty breathing did not get any more severe, and she stabilized as he checked in with her periodically on the way home. She arrived at the Hospital Emergency Department a little before 11:00 am.  In the emergency room, she was diagnosed by sonogram for DVT in her right femoral vein. A chest x-ray was taken and due to the patient's symptoms a pulmonary embolism was inferred to be the cause without further need of investigation by CT scan due to the increased risk for pregnant females. She was treated with a shot of low molecular weight heparin (LMWH) and continues to get a LMWH subdermal shot every twelve hours for the duration of her pregnancy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Exposure during pregnancy, Fatigue, Insomnia
Clinical narrative: THE MORNING AFTER VACCINE ADMINISTRATION, DUE TO SEVERE CHEST PAIN, PATIENT WAS TAKEN TO EMERGENCY DEPARTMENT AT HOSPITAL. PATIENT WAS DIAGNOSED WITH SUSPECTED PULMONARY EMBOLISM (PE), AND DVT WAS CONFIRMED USING SONOGRAM IN RIGHT LEG FEMORAL REGION. PATIENT WAS THEN ADMITTED TO THE ICU FOR FURTHER MONITORING. The first dose of the vaccine (Moderna 001C21A) was given on 23 April 2021. The patient had a sore upper arm and no other significant observations. She had no other pain, issues, or health concerns of any kind. It was the second trimester in her pregnancy so walking and moderate exercise did not lead to any pain or shortness of breath.   The second dose of the vaccine (Moderna 033C21A) was administered on 2 May 2021. That afternoon, she began feeling progressively tired and uncomfortable. During the night she was feverish, anxious, could not sleep, and began feeling unwell. The next morning she could not move around normally, was becoming short of breath, and discovered a sharp pain in her right leg when she put weight on it that felt like a string being pulled tight. Around 8:00 am, she began having chest pain. By 9:30 AM she had severe chest pain and was having difficulty breathing. She called her husband to report her situation, and he immediately left work to take her to the emergency room because she had to pause in the middle of sentences to catch her breath. He was almost an hour drive away and instructed her to call an ambulance if the difficulty breathing became any worse. Luckily, her difficulty breathing did not get any more severe, and she stabilized as he checked in with her periodically on the way home. She arrived at the Hospital Emergency Department a little before 11:00 am.  In the emergency room, she was diagnosed by sonogram for DVT in her right femoral vein. A chest x-ray was taken and due to the patient's symptoms a pulmonary embolism was inferred to be the cause without further need of investigation by CT scan due to the increased risk for pregnant females. She was treated with a shot of low molecular weight heparin (LMWH) and continues to get a LMWH subdermal shot every twelve hours for the duration of her pregnancy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Malaise, Mobility decreased, Pain in extremity, Pulmonary embolism
Clinical narrative: THE MORNING AFTER VACCINE ADMINISTRATION, DUE TO SEVERE CHEST PAIN, PATIENT WAS TAKEN TO EMERGENCY DEPARTMENT AT HOSPITAL. PATIENT WAS DIAGNOSED WITH SUSPECTED PULMONARY EMBOLISM (PE), AND DVT WAS CONFIRMED USING SONOGRAM IN RIGHT LEG FEMORAL REGION. PATIENT WAS THEN ADMITTED TO THE ICU FOR FURTHER MONITORING. The first dose of the vaccine (Moderna 001C21A) was given on 23 April 2021. The patient had a sore upper arm and no other significant observations. She had no other pain, issues, or health concerns of any kind. It was the second trimester in her pregnancy so walking and moderate exercise did not lead to any pain or shortness of breath.   The second dose of the vaccine (Moderna 033C21A) was administered on 2 May 2021. That afternoon, she began feeling progressively tired and uncomfortable. During the night she was feverish, anxious, could not sleep, and began feeling unwell. The next morning she could not move around normally, was becoming short of breath, and discovered a sharp pain in her right leg when she put weight on it that felt like a string being pulled tight. Around 8:00 am, she began having chest pain. By 9:30 AM she had severe chest pain and was having difficulty breathing. She called her husband to report her situation, and he immediately left work to take her to the emergency room because she had to pause in the middle of sentences to catch her breath. He was almost an hour drive away and instructed her to call an ambulance if the difficulty breathing became any worse. Luckily, her difficulty breathing did not get any more severe, and she stabilized as he checked in with her periodically on the way home. She arrived at the Hospital Emergency Department a little before 11:00 am.  In the emergency room, she was diagnosed by sonogram for DVT in her right femoral vein. A chest x-ray was taken and due to the patient's symptoms a pulmonary embolism was inferred to be the cause without further need of investigation by CT scan due to the increased risk for pregnant females. She was treated with a shot of low molecular weight heparin (LMWH) and continues to get a LMWH subdermal shot every twelve hours for the duration of her pregnancy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Ultrasound scan abnormal, Weight bearing difficulty
Clinical narrative: THE MORNING AFTER VACCINE ADMINISTRATION, DUE TO SEVERE CHEST PAIN, PATIENT WAS TAKEN TO EMERGENCY DEPARTMENT AT HOSPITAL. PATIENT WAS DIAGNOSED WITH SUSPECTED PULMONARY EMBOLISM (PE), AND DVT WAS CONFIRMED USING SONOGRAM IN RIGHT LEG FEMORAL REGION. PATIENT WAS THEN ADMITTED TO THE ICU FOR FURTHER MONITORING. The first dose of the vaccine (Moderna 001C21A) was given on 23 April 2021. The patient had a sore upper arm and no other significant observations. She had no other pain, issues, or health concerns of any kind. It was the second trimester in her pregnancy so walking and moderate exercise did not lead to any pain or shortness of breath.   The second dose of the vaccine (Moderna 033C21A) was administered on 2 May 2021. That afternoon, she began feeling progressively tired and uncomfortable. During the night she was feverish, anxious, could not sleep, and began feeling unwell. The next morning she could not move around normally, was becoming short of breath, and discovered a sharp pain in her right leg when she put weight on it that felt like a string being pulled tight. Around 8:00 am, she began having chest pain. By 9:30 AM she had severe chest pain and was having difficulty breathing. She called her husband to report her situation, and he immediately left work to take her to the emergency room because she had to pause in the middle of sentences to catch her breath. He was almost an hour drive away and instructed her to call an ambulance if the difficulty breathing became any worse. Luckily, her difficulty breathing did not get any more severe, and she stabilized as he checked in with her periodically on the way home. She arrived at the Hospital Emergency Department a little before 11:00 am.  In the emergency room, she was diagnosed by sonogram for DVT in her right femoral vein. A chest x-ray was taken and due to the patient's symptoms a pulmonary embolism was inferred to be the cause without further need of investigation by CT scan due to the increased risk for pregnant females. She was treated with a shot of low molecular weight heparin (LMWH) and continues to get a LMWH subdermal shot every twelve hours for the duration of her pregnancy.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hemiplegia, Magnetic resonance imaging, Pyrexia, Scan
Clinical narrative: HAD PARALYSIS ON ONE SIDE WITH NO USE OF ONE OF LEG; FEVER; This spontaneous report received from a patient via a company representative concerned a 3 decade old (around 22-24) female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraine (Consulted neurologist), and other pre-existing medical conditions included: Patient never had symptoms of Covid and no known exposure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 3 decade old. No concomitant medications were reported.  On an unspecified date, about 1 hour after receiving the vaccine, the patient experienced a fever of 103, which was very strange since this was only the 3rd time having a fever in life. Patient also experienced tingling and numbness (one side of the body-this eventually went to one leg and lost mobility on that side). Patient visited urgent care and was prescribed anti nausea medications which was not helpful. Patient experienced paralysis on one side with no use of one of leg (side is unspecified). There was 9 months of intensive therapy. Patient has seen neurologist, nothing showed up like a stroke or anything else like a micro clot. Patient had multiple scans, MRI (magnetic resonance imaging), and all are inconclusive. The patient visited emergency room and physician office visit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from had paralysis on one side with no use of one of leg, and the outcome of fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230118828-Had paralysis on one side with no use of one of leg-The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Confusional state, SARS-CoV-2 test positive
Clinical narrative: Hospitalization: 12/30/2022 - 1/6/2023 (7 days) Presentation to the ED: INCREASED CONFUSION.  COVID + date: 12/30/22. Treatment: STEROIDS.  Discharge to: Home.   030A21A 3/3/2021 036B21A 4/5/2021
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 5-6 weeks before got sick from covid; 5-6 weeks before got sick from covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The 5 th dose was 5-6 weeks before the patient got sick from covid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Oct2022, outcome "recovered" (17Nov2022) and all described as "5-6 weeks before got sick from covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: This was the first time the patient had covid symptoms and tested positive; (15Nov2022) Positive, notes: Still positive; (17Nov2022) Negative, notes: then it took another 3 weeks to completely recover. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid. The patient was exposed to covid on 23Oct2022, had mild symptoms on 26Oct2022, and moderate symptoms on 29Oct2022.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Middle ear disorder, SARS-CoV-2 test
Clinical narrative: 5-6 weeks before got sick from covid; 5-6 weeks before got sick from covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The 5 th dose was 5-6 weeks before the patient got sick from covid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Oct2022, outcome "recovered" (17Nov2022) and all described as "5-6 weeks before got sick from covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: This was the first time the patient had covid symptoms and tested positive; (15Nov2022) Positive, notes: Still positive; (17Nov2022) Negative, notes: then it took another 3 weeks to completely recover. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid. The patient was exposed to covid on 23Oct2022, had mild symptoms on 26Oct2022, and moderate symptoms on 29Oct2022.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 at 10:00 as dose 1, single (Lot number: EW0151), in arm and on 05May2021 at 10:00 as dose 2, single (Lot number: ER8731) at the age of 55 years, in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2019 (ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus, start date: 2019 (ongoing); ATORVASTATIN taken for blood cholesterol abnormal, start date: 2020 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2021, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Hearing loss: (07May2021) Unknown Results; Magnetic resonance imaging: (10May2021) Normal; SARS-CoV-2 test: (07May2021) Positive, notes: No Symptoms.  Clinical course: No prior vaccinations within 4 weeks of COVID vaccine. No Specific Relevant Test For Thromboembolic Events With Thrombocytopenia. At the emergency room, they told patient that she was positive for Covid and they sent her to a room. She never had any Covid symptoms when She lost hearing. She had no fever or body aches and so on. She always wore a mask at work or outside.
Age: 29.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case    all Pfizer dose 1 3/10/21 EL9267 dose 2 3/31/21  ER8727 dose 3 12/16/21  33130BA  vaginal delivery on 1/4/23, 39.3 wga
Age: 29.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, Delivery, Exposure during pregnancy, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case    all Pfizer dose 1 3/10/21 EL9267 dose 2 3/31/21  ER8727 dose 3 12/16/21  33130BA  vaginal delivery on 1/4/23, 39.3 wga
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Headache, Paraesthesia, Skin warm
Clinical narrative: Probably within five minutes of getting the vaccine, I went to go sit down and wait. I immediately had a headache and it felt like my deltoid where they had given me the shot was really sore, like something had hit it. Then I felt it spread down towards my left hand and a neuropathy. I went to tell the nurse. I also felt some pain under my armpit and part of my chest. She enrolled me in VSafe and told me to get some BENADRYL. When I went home about 20 mins later I started to have numbness and tingling in my other hand and that night I had the same feeling in my feet. I spent most of the day Tuesday in bed, I took some BENADRYL and had a low grade fever of 99. The next day, I think it was Wednesday. I had a fever of 100.6, and then that broke and I haven't had any fever since then. I lost my appetite and had muscle aches and pain, sneezing and coughing, and a lot of mucus. I called the doctor's office for an upcoming procedure to tell them and they told me to test for COVID-19. I did and tested positive on Thursday. I called my PCP and they set up a tele-health appt. They recommended I take PAXLOVID and discussed underlying conditions. I started that last night. My heart rate has been a little high, doctor told me to monitor it, but it has come down since the appt.