chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions and allergies were not specified. On 26-SEP-2014, the patient was vaccinated with a first dose of PNEUMOVAX 23 0.5 ml, intramuscularly (lot number and anatomical site were not reported). On an unknown date in 2014, the patient was hospitalized for unspecified reason and duration. On 02-OCT-2014, the patient was vaccinated with a second dose of PNEUMOVAX 23 0.5 ml, intramuscularly (lot number and anatomical site were not reported) while being hospitalized. The patient did not seek medical attention. The outcome of hospitalization was unknown. The relatedness between the hospitalization and PNEUMOVAX 23 was not reported. Additional information is not expected because consent for follow up was not obtained.
Acute pain on site of injection, limited mobility of left arm still present at the time of writing (5 days since injection) Restlessness and insomnia due to pain lasting for 3 days. Acute pain on arm pit of left arm lasting for 3 days.
Patient brought to the ED via EMS on 9/27 for weakness. He tested positive for COVID on 9/22 by home test. Of note, the patient currently has lung cancer and restarted chemotherapy 4 days ago after 3 months off from previous chemo. He also had a temperature at home of 100.8 F. Patient was placed on supplemental oxygen, and had another COVID test done in the ED which was positive. He was admitted from 9/27-9/28. Discharge diagnoses include acute hypoxic respiratory failure with left lower lobe pneumonia, COPD exacerbation; sepsis; and COVID-19. Patient has received the COVID vaccine and two booster shots.
Patient came to get her third PFIZER vaccine. After 15 minutes, the technician asked her if she was feeling well and she reported that she felt a little fatigued and had nasal congestion. I asked her if she had any such experiences or had asthma and she told me that since starting her PFIZER doses she had begun to feel fatigued but had not been diagnosed with asthma or any other illness. I told her to stay 15 more minutes in the room and that she could call 911 if she wanted and offered her BENADRYL. After 15 minutes she told me she had a stuffy nose and declined the 911 call and the BENADRYL because she had to drive home. I told her if any events happen eventually to call us. She was grateful for our attention.
Moderna Dose 1 3/27/21 (007B21A) Moderna Dose 2 4/23/21 (040B21A) Covid Positive 1/17/22  1/23/21: History of Present Illness The patient is a 73-year-old gentleman who has past medical history significant for COPD and is oxygen at home.  It seems that he was feeling sick for a couple of days and he had come to the emergency room for it on January 17, 2022. He was discharged home on prednisone and doxycycline for seven days.  It seems that he came back to the emergency room overnight with shortness of breath.  He was unable to give a good history.  He had come by ambulance.  It seems that he was short of breath even earlier and ambulance was called but he decided not to go to the ER.  He was finally about to the emergency room today morning around 4:30 a.m.. He was quite short of breath when he came and had VBG that showed pH of 7.34 with pCO2 of 75.  He has had blood gas in the past were pCO2 has been lower.  His urine drug screen was positive for unconfirmed barbiturates.  He was given oral azithromycin 500 mg along with some magnesium for low magnesium.  He also got some Haldol and 6 mg of Decadron. It was thought that his  blood gases better and he can go to the floor. His pulse ox was 84% on 2 L in the ER and is also on 60% FiO2 with the BiPAP earlier which was weaned down to 40%. when I went to see him he was only on mask. He seems to be better than before.  He states shortness of breath was moderate to severe intensity and oxygen help. It is currently improved as compared to when he came. There is no other apparent aggravating or aleviating factor.  He still is out of bed though better than before and review of system and history was difficult to get and also not completely reliable.  1/25/22: Patient is a 73-year-old male with history of HTN, HLD, CKD 3, obesity, DM, pulmonary fibrosis, non-small cell lung cancer, chronic AFib on Eliquis, and chronic hypoxic respiratory failure with home O2 who was admitted on 1/23/2022 with bilateral COVID pneumonia, acute COPD exacerbation, and acute hypercapnic respiratory failure. He was admitted to the medical floor and was started on on Azithromycin, ceftriaxone, dexamethasone, and remdesivir. He was placed on BiPAP on admission.  He has recovered fairly quickly, and is back to his home O2 use.  He has been ambulating in the room with minimal assistance.  He is requesting to go home today.  He denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations. Physical therapy evaluated the patient and felt he would be safe to go home with family care or with VNA services.  The patient was agreeable to physical therapy and nursing services as well as at home program.
I got the shot by the pharmacist and immediately it hurt as she gave it. More than normal (I've gotten the flu shot for ten years).  I immediately had soreness and it worsened over the evening. I could barely raise my arm without pain. By the next day it was so bad I couldn't shower, dress, drive or move it without extreme shooting pains down my arm. It radiated into my neck and back. I took Ibuprofen and used heat on it with no relief. Red sore bump at injection site and the top of my shoulder. She clearly didn't give the shot where she was supposed to. By Tuesday (2 days after) it was even worse. Called pharmacist, she said this was rare, and to take pain meds and go to my doctor if it didn't stop. Just went to my family doctor and they prescribed physical therapy and prescription anti-inflammatory drugs. It is still very painful and I am very limited in the use of my arm.
On 10/17/18 patient presented to office with redness and swelling to right arm. Patient stated it had started to get warm, turn red, and swell the day following the vaccine. Dr. was advised and saw patient. He administered BENADRYL 25mg PO once and Ibuprofen 600mg PO once. He instructed patient to go to ED if symptoms worsened and to report back to clinic next day.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.   No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
ADMINISTRATION (scheduling) ERROR:  Vaccine administered too early / too close together Patient received the 2nd dose of Covid Vaccine before the 21 day timeframe. She was early by 5 days.
swollen lymph nodes to left arm pit; headache; fatigue; severe neck pain; This is a spontaneous report from a contactable health care professional (nurse), the patient.   A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: eha899), in the left arm on 06-JAN-2021 12:00 as a single dose, for COVID-19 vaccination.  The most recent COVID-19 vaccine was administered was a Nursing Home/Senior Living Facility. Medical history included covid-19 (prior to vaccination) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included duloxetine hydrochloride (CYMBALTA), omeprazole (PROTONIX [OMEPRAZOLE]). On 07-JAN-2021 05:00, The patient experienced swollen lymph nodes to left arm pit, headache, fatigue, severe neck pain..  No treatment was  given for the event. . No other vaccines were given within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of swollen lymph nodes to left arm pit,  headache, fatigue and severe neck pain.was not recovered.
Rash-pink, red, papules varying sizes, several scabbed on head. No vesicles, afebrile, no vomiting or diarrhea. Chicken pox diagnosed by the physician.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age. Starting from 06-AUG-2015, the patients were inadvertently vaccinated with an improperly stored dose of ROTATEQ, LOT #K013411, 19-MAR-2016, K010325, 10-MAY-2016, K014826, 28-MAY-2016, L004466, 02-AUG-2016. No adverse reactions were reported. The outcome of the events were unknown. This is one of the 4 linked cases received from the.
Pt recvd vax 20MAY92 & & 27MAY92 pt devel diarrhea w/flu-like sx & lightheadedness;
Patient diagnosed with pericarditis at the ER 2d after receiving his booster (4th dose) of the Pfizer COVID-19 immunization. He has not had any prior reactions to this vaccine or any others.
swelling, lump in left deltoid. Warm to touch and very sore. Follow up report received 02/22/2005:  Vaccine Manufacturers and lot numbers updated.
Information has been received from a registered nurse concerning a 7 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was not known. There was no product quality complaint involved. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GH9694) at the age of 28 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 at 12:45 as dose 1, single (Lot number: EP6955), in left arm, on 18Apr2021 at 12:30 as dose 2, single (Lot number: ER8731), in left arm and on 02Nov2021 at 17:45 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19". Clinical course: After taking a full 5 day course of Paxlovid, and testing negative on an antigen test multiple times subsequentially for 7 days, the patient had tested positive again for Covid and was experiencing rebound symptoms from 18Oct2022 at 06:30 am. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: testing negative on an antigen test multiple times subsequentially for 7 days; (2022) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of covid-19, which included PAXLOVID, acetaminophen (TYLENOL), and ibuprofen (ADVIL) all from 04Oct2022 to 09Oct2022.  No follow-up attempts are possible. No further information is expected.
From initial information received on 09/02/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a patient (one of five) in the age range of 15-18 months, received DAPTACEL vaccination, lot number C1698AA on an unspecified date. No specifics were provided regarding the dose, route, or site of the vaccine. Reportedly sometime after the vaccination the patient was treated with antibiotics fro injection site cellulitis. The patients recovery status is currently unknown. The reporter of this case is the same reporter of cases: 200402947, 200402948, 200402949, and 200402950.
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is four of eight. See A0956566A, A0956567A, A0956568A, A0956570A, A0956571A, A0956572A and A0956573A for details regarding the additional cases.
Scared; Fever, today 99.2 degree F, was sick in bed 3 days with 102.8 degree F; Sick; Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ILLNESS (Sick), FEAR (Scared), PYREXIA (Fever, today 99.2 degree F, was sick in bed 3 days with 102.8 degree F) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Jan-2021, the patient experienced ILLNESS (Sick) and PYREXIA (Fever, today 99.2 degree F, was sick in bed 3 days with 102.8 degree F). On an unknown date, the patient experienced FEAR (Scared). At the time of the report, DIZZINESS (Dizziness), ILLNESS (Sick), FEAR (Scared), PYREXIA (Fever, today 99.2 degree F, was sick in bed 3 days with 102.8 degree F) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included advicodid, acetaminophen, aspirin, caffeine .
All condition that my body desvallate for the ANTHRAX shot have a yellow mark in the next pages. At this time I'm very sick for that and am confirm sick very sick. abdominal pain, ache: joints and muscles, allergies, appetite: loss, arthritis, asthma, balance: dizzy upon standing, vertigo and dizziness, balance problems, blood pressure high, blood high cholesterol, respiratory bronchitis, bumps on hand, cold and flu-like symptoms, concentration trouble, cough, cramps leg, dehydration, delirium episodes, delirium, depression, dermatitis exfoliative, dermatitis, diabetes mellitus, diarrhea constant, digestive gastric ulcer, nausea constant, digestive problems, pancreas, eczema vaccinatum, eczema, edema face, genital edema, energy loss, fatigue, gastritis, hair turned white then brown, head rushes, headache uncontrollable thump on left side of head, evolving into headache, migraines, headache continuous, ringing in ears, poor tolerance for loud noises, vomiting blood, herpes simplex, hyperglycemia, hypertension, hypothyroidism, immune system problems weakness autoimmune disorder, impotence, constant infections, joint aches, memory difficulty, memory loss, trouble remembering recent information, anxious mood angry mood, irritable mood, runny nose, nausea, nausea and vomiting and diarrhea, nervousness anxiety, numbness and tingling in fingers and arms, pain in legs lower back right shoulder hips leg right hip chest groin back, lower back pain, joint and muscle pain and stiffness, stomach pain, bone and joint pain, arthritic pain, neck pain, abdominal pain, pain in feet like electrical shocks, rash macular papular, burn type rash on entire body, respiratory problems, sinusitis, itching skin, spontaneous burning sensation on skin, infected wounds, skin sensitivity, skin papules filled with clear fluid when papules broke fluid burned skin and was extremely painful, skin pain, need stimulant to stay awake, sleep problems, sneezing, stomach problems, suicide attempt, shrunken testicles, tinnitus, tremors, ulcer skin, urinary frequency, vision poor tolerance for bright lights, vision problems, voice alteration, walking trouble walking difficulty, weight gain weight loss. 11/9/07-clinic records received-C/O episodes of irritability anxiety with sleeping disturbances awakening for minimal noise. Headaches, diarrhea, paresthesia on hands, skin condition while in middle east. Flashbacks, nighmares,  Difficulties coping with civilian life. DX: Gastroesophageal reflux disease. Major depression. Chronic low back pain. Post traumatic stress disorder. Obese. HypeDiabetes Mellitus Type 2 . Toxic multinodular goitor (subclinical hypothyroidism).rglycemia. Sleep apnea. Hypertriglyceridemia. Chronic smoker.
Headache - about 20 hours duration from onset of symptoms - onset about 8 hours after injection Vomiting (one time) - onset about 8 hours after injection low grade fever for approximately 20 hrs duration (99.3-99.6 - oral) - onset about 8 hours after injection Tiredness - onset about 8 hours after inject - duration about 20 hours
CLIENT RECEIVED PNUEMOCOCCAL VACCINE AND FLU VACCINE ON THE 9/24/09 IN THE RIGHT DELTOID. THE FLU VACCINE WAS GIVEN AT 10:33AM AND THE PNEUMOCOCCAL WAS GIVEN AT 10:34AM. ON 9/26/09 IT WAS NOTICED THAT THE RIGHT ARM WAS RED,HOT AND EDEMATOUS.
The area surrounding the injection, approximately 2 inches in each direction turned red, had a rash and was also hot to the touch.  This reaction continues over 2 weeks after the injection and she is still not completely recovered.
Massive abscess developed in the gum area of the roof of the mouth.  This happened within hours of the vaccination. Called the doctor and was prescribed antibiotics right away. Was told to also apply hot towels to side of face and gargle with salt water till the infection drained.  If it didn't drain, was instructed to go to the hospital. It mostly drained within 2 hours of hot towels and salt water gargle. It was mostly blood and some fluid that drained out. 24 hours later, it was gone. Finished the antibiotics completely as instructed by doctor.
The evening vaccines were given pt was inconsolable for 22 hrs, unusual high pitch & sl elevation in temp; this episode lasted about 24 hrs;
typical fever chills, body aches for 48 hours. Couldn't get out of bed.     Then just felt like I was in a fog for 3 weeks.  Hard to explain, but just didn't feel "right".  Hard to focus, didn't have the energy like I usually have.  Normally I am active and healthy.  I feel fine now.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 07/29/2022, LOT #006M21A. 8/5/22 pt presents to ED in cardiorespiratory arrest; was found in asystole; CPR performed; intubated; defibrillated and medications given; had a positive COVID test in SNF on 8/4/22; pt unable to be resuscitated and passed away in the ED (Hospital)
Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head was spinning so fast I would pass out. When I would wake up, I was so nauseated that I tried to throw up but hadn't eaten anything, so I had dry heaves. I would wake up and repeat this process over and over. After about 6 hours the dizziness got better but I could not walk by myself as I was so wobbly and weak. My husband tried to get me to the car to take me to the ER but I couldn't stand up. I felt a little better the next day (Sunday) but was unable to keep anything down. I slept a lot as I felt exhausted. I was unable to work on Monday or Tuesday as I was still very disoriented. I would periodically had dizzy spells where I thought I was going to pass out, so when I went back to work on Wednesday, my husband drove me to work and picked me up. At work, when walking I still was very unsteady on my feet and kind of had to hold onto the wall to keep my balance. This stayed with me thru the next week. I felt better the following week and have not had any other issues.
Initial unsolicited report received from consumer on 15-Jan-2018. This case involves female patient (age reported as 61 unit unspecified) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 31 Oct 2017. The patient's medical history and concomitant medications were not reported. On 01 Nov 2017, one day following the vaccination, the patient experienced pain in her fingers, then pain in her feet and ankles. Reporter states ongoing joint pain. Patient has been to podiatrist, and to her physician, the patient was treated with prednisone which caused her had heart rate to race on an unknown date. It was also stated that the patient cannot walk some days and its hurts all over. Lab data was not reported. Corrective treatment includes prednisone. The patient had not recovered from the events. This case was reported as serious due to disability. List of documents held by sender: none.; Sender's Comments: Patient experienced pain in ankle and pain in extremity after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.