chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; Cough; Chills; Headache; Body aches; Joint pain; Arm pain; Swollen lymph node (left under arm), Swollen lymph nodes in neck; Fever; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Ew0172), via an unspecified route of administration in left arm on 29Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation. Medical history included asthma, depression and insomnia/sleep disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA ALLERGY), mometasone furoate (FLONASE) and vitamin D. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation; iodine and experienced drug allergy. On 30Apr2021 at 20:00, the patient experienced chills, headache, body ache, joint pain, arm pain, swollen lymph node (left under arm), swollen lymph nodes in neck, fever (99-101 while taking paracetamol (TYLENOL)), severe fatigue. Started on 02May2021, patient experienced sore throat and cough, continued fatigue, continued fever, swollen lymph nodes in neck. As of 05May2021, sore throat, cough, fatigue, swollen lymph nodes in neck and fever were still present. Cough had worsened. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as result of fever included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of the events sore throat, cough, fatigue, swollen lymph nodes in neck and fever was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt vaccinated with Engerix-B woke up with pain, temp 100, still aching.
Pt. received flu vaccine 10/11/12, said arm started hurting 10/13/12, came in 10/16/12 to see if sore arm, radiating into back was normal.
Within minutes of receiving the shot, I developed nausea; within an hour or less I had severe abdominal pain and nausea; Everytime I ate I became more nauseous and had pain; still can not eat anything and have lost 30 pounds because of it; Initial information received on 14-Mar-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who experienced within minutes of receiving the shot, i developed nausea, within an hour or less i had severe abdominal pain and nausea, every time i ate i became more nauseous and had pain and still can not eat anything and have lost 30 pounds because of it while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (Strength, formulation, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.    On an unknown date the patient received the flu shot at the end of October. Within minutes of receiving the shot, she developed nausea (Nausea) (latency :unknown) and then within an hour or less she  had severe abdominal pain and nausea (Abdominal pain) (latency :unknown). Being a nurse she tried to tough it out and care for her symptoms myself. However, she wasn't able to control her symptoms. Days/weeks pasted and she still had severe pain and nausea. Every time she ate became more nauseous and had pain(Condition aggravated) (latency :unknown). she finally seemed medical help. My labs, x-ray, EGD and colonoscopy are unremarkable. However she still can not eat anything and have lost 30 pounds because of it(Weight decreased) (latency :unknown). she told all my doctors that her problems happened minutes after the flu shot but no one wants to listen to it. But as a nurse she believe it needs to be reported.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events
This spontaneous report was received from a medical assistant regarding a 3 month old patient of unknown gender. The patient's concurrent, historical and concomitant medications were not reported. On 16-NOV-2018, the patient was vaccinated with VARIVAX lot number R012531 and expiration date of 01-MAY-2020 (dosage, frequency, strength, route of administration were not reported) for prophylaxis. The patient's vaccination was outside the recommended age according to the prescribing information. No adverse events was reported.
Patient complained of severe headaches on and off for 3 to 5 days following vaccine. Also complained of low body temperature the first day of vaccine.
Has bubbly rash where vaccine was received. Has blisters on buttock and ear and cheek.
COVID symptoms that lasted  about 18 hours (cough; tired; chills; confusion)
Patient's representative called on 11/2/2021 stating that the patient received second dose of Pfizer on 10/30/21 and still has pain in the arm and bleeding at the spot where the vaccine was injected. Patient had bleeding on Saturday night(10/30),then no bleeding on Sunday and Monday and bleeding started again on Monday. Per patient's representative p-t is not on Aspirin, blood thinner or NSAIDs. I asked patient to apply a bandage and said that discomfort at the injection site is to be expected and may last up to several days. I asked to contact PCP if bleeding at the injection site worsen or do not subside.
Generalized maculopapular rash on face, trunk and extremities and low grade fever (100.8) onset 2/26/2000  16 days post vax.
Patient is a 60 y.o. female  Chief Complaint Patient presents with ? Cough     husband positive ? Fever ? Sore Throat ? Generalized Body Aches
Immunizations given 1/16/12.  Developed 2-inch diameter reddened, swollen area on left arm deltoid area.  No fever. Father to bring patient to see M.D. 1/18/2012.
One week after injection   Hives , swelling , warm to touch at injection site   Next date increased redness increased size    Virtual appointment with Heath care provider   Dx allergic reaction   Recommend hydrocortisone cream to site.
Dose 1: 3/10/21 Dose 2: 3/31/21 Booster: 9/23/21
Unable to lift arm above shoulder height, whole arm and shoulder in pain. Unable to lift anything with right arm.
Pt. presented with shortness of breath and tingly lips. Pt. was ambulatory and A/O x4. Pt. was moved to Private Treatment area for further monitoring, P.T. stated he had a history of CHF. Pt was advised to Remove mask while being observed (P.T. was masked with 2 very tight fitting masks.) Vitals were obtained x3 showing normal results. PT. felt much better after 30 min monitoring period. PT. was advised to seek medical attention if needed. BP 139/94, P 83, Resp. 18, SPo2 98%. BP 137/84, P 86, Resp 18, SPo2 98. BP 136/91, P 85, Resp. 15, SPo2 97.
This is a spontaneous report from a contactable consumer (patient).    A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, expiration date not provided),  2nd dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 at age of 55 years old as a single dose for COVID-19 immunisation; mepivacaine hcl (manufacture unknown), via an unspecified route, date, dose for an unspecified indication. Medical history included Shingles. Concomitant medication included enalapril maleate (VASOTEC) taken for blood pressure. The patient previously took morphine and experienced allergies, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265, expiration date not provided),  1st dose via an unspecified route of administration, administered in Arm Left on 11Feb2021 as a single dose for COVID-19 immunisation. The patient experienced guillane-barre syndrome, tingling and numbness in the legs, arms and lower face, severe headache, imbalance, disorientation, muscle spasms, diarrhea, all on 16May2021.  The action taken in response to the events for mepivacaine hcl was unknown. The outcome of the events was not recovered. No treatment received for the events. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Pfizer is a marketing authorization holder of [mepivacaine hcl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [mepivacaine hcl] has submitted the same report to the regulatory authorities.
Awakened from sleep at 10:30 p.m. with sense of nervousness, slight tightness in chest, and an increase in effort to breathe. This is the sensation I get when my asthma has been triggered. It is NOT of cardiac origin. Took 2 puffs of albuterol inhaler with relief of chest tightness and able to breathe easier.. When asthma is triggered, I also have a very difficult time sleeping. I have a RX for ambien for such occasions. I took a half a ambien, and was able to fall asleep.  I did need the inhaler again in the morning. No chest tightness but the sense of needing to breathe easier.  I took 2 puffs of albuterol which enhanced my breathing effort. I plan to keep my inhaler readily available over the next few days to use prn. I had this same reaction about 20 years ago with the flu vaccine. I have had the COVID (Pfizer vaccine) and did not have any respiratory issues, which is why I thought I would try the flu vaccine again.  I know that if I keep my asthma triggers well controlled, my asthma remains well controlled. Consequently, I am proactive to anything that may trigger my asthma to prevent any exacerbation of my symptoms.
Chest pain Acute kidney failure, unspecified DOE (dyspnea on exertion) Hypoxia Bilateral pleural effusion Chronic obstructive pulmonary disease, unspecified COPD type  Chronic kidney disease, unspecified CKD stage Acute on chronic heart failure with preserved ejection fraction
06/22/2021 - I started getting painful lumps under my arm which turned to blisters, scratching throat, sinus pressure
Two week after receiving the Moderna vaccine, patient started to have a high fever, body aches all over, coughing, congestion, and oxygen levels would not remain stable.  On 3/15 she was admitted the hospital. She is still currently in the hospital and her blood oxygen levels remain around 80. She has fluid in her lungs and around her heart. Her liver enzymes remain highly elevated.
PE; DVT; A spontaneous report was received from a pharmacist concerning patient (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a pulmonary embolism (PE) and deep vein thrombosis (DVT).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a PE and DVT. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, PE and DVT, were not reported.; Reporter's Comments: Very limited information regarding the reported evens have been provided at this time.  No additional  information is expected as consent to follow up was denied.
Cardiologist seen. Who specialist in valves. Detected calcium build up in aortic valve. And was monitored for that, and when I went back and it was more progressed and accumulating faster then expected. Was told to come back in 6 months. Then went back and it was the same thing. Then told to go back in 3 months. Told to participate in clinical trial. Had to test to be included, and one of the 2 doctors that was running clinic trial told me I was severe zone for aortic stenosis and was told I could have valve replaced. Was told did not need open heart surgery, they can do it with a catheter, and had a trans cathedralic valve replacement this year.
Recvd vax 1230 pm.@ 8pm that night mother fed pt&pt was ready to sleep-sat up&vomited soon /p arms&legs went stiff&began to shake X 2min.@ 845pm had 104 T,clingy.Spoke to MD treating vomiting /w Pedialyte.T intermittant.Dec appitate&sleep.
2nd Covid 19 shot I got the second Moderma 35 days after the first one.   About hour one after the shot, my upper bladder/lower stomach was so sore that I had a hard time standing and walking for about 24 hours. About hour two, my arm got very sore where I had received the shot.   About hour three, I got nauseous and stayed nauseous for about 24 hours. About hour four, I was so tired that I laid still for about 20 hours. About hour 12 I had new aches and pains everywhere that lasted for a whole day. About hour 26 I ran a very high temperature for about 10 hours.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-365121 (Patient Link).
pt recvd ax on 4NOV93 & 24 hrs following vax devel severe pain @ the inject site, redness, swelling & felt hot; sx extended down arm & hand; pt seen by MD who felt that sx were due to cellulitis;
Patient received MENVEO vaccine two days ago. The afternoon of vaccine the arm was warm and achy that has continued to worsen. The patient started to have blisters yesterday. The patient received ibuprofen yesterday x 2 and last night a dose of BENADRYL x 1. The patient has redness, warm to arm and extending to cheek. The area also itches but denies pain. (Note taken directly from Dr.'s office visit).
Child rec'd 5 vaccines. Saturday, mom noted child sleepy that afternoon. Noted redness, swelling on face, trunk, ears; itching upper arm and a fever on Sunday morning. Taken to physician today, 4/10/06 AM. RX for Hydroxyelle and ointment given of Locoid Lipocream. Observed child 4/10/06 here. Checked with mom this PM. Improvement in rash and itching. Taking medications/recovering/improvement.
Patient developed lip  and tongue swelling and came to the Emergency Department on 2/14/21. She was admitted for observation. Also gave a history that on 2/13 too her lisinopril, had a seafood dinner with some wine. She awoke on 2/14 with swelling, took some Benadryl, went to the Urgent treatment Center and received a Decadron prior to trip into the Emergency Department where she was admitted, observed and discharged on 2/15/21.
Pt devel abd pain, flu-like sx, arthralgia & myalgia w/in 24 hrs p/recvd 3rd dose of Hep B; had no rxn following the 1st & 2nd doses;
Day after MMR administered, lethargy, tiredness set in. Patient could not bike more than a block. Wanted to rest at home. Within 6 days a fever started. Spiked at night. 102 degrees. Fever lasted three days. Finally felt energy again on October 20th.
Leg swollen, shortness of breath. Mom stated allergic to VARIVAX event though she got MMRV.
pt is complaining that arm is swollen, she says the throbbing and redness has decreased but is still there after 6 days. she says it is getting better though but is worried about how long it was
getting blisters in her mouth, on her gums, and down her throat; getting blisters in her mouth, on her gums, and down her throat; getting blisters in her mouth, on her gums, and down her throat; got an infection in her eyes where both of her eyes were sealed shut; having sensitivity to light; her hands and wrists look like psoriasis like her whole body gave up; more pain than she imagined she could take; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 12Sep2021 as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide (ARAVA) taken for an unspecified indication, for last 8 years from an unspecified date, upadacitinib (RINVOQ) 50 mg twice a day taken for an unspecified indication from Jul2021 to an unspecified stop date (2.5 months). On unspecified date in Sep2021 the patient experienced getting blisters in her mouth, on her gums, and down her throat, got an infection in her eyes where both of her eyes were sealed shut, having sensitivity to light, her hands and wrists look like psoriasis like her whole body gave up and more pain than she imagined she could take. States she doesn't know if this is related to her biologic. Patient asked if these are symptoms of receiving the vaccine. Patient didn't know if it was a mix of going off of the immunosuppressant drug and is scared of getting the next shot. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
She even hallucinated; The vaccine made her very sick; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (She even hallucinated) in a 57-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (She even hallucinated) (seriousness criterion medically significant) and ILLNESS (The vaccine made her very sick). At the time of the report, HALLUCINATION (She even hallucinated) and ILLNESS (The vaccine made her very sick) had resolved.        The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Treatment information was not provided.  Company comment: This spontaneous case concerns a 57-years-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) Hallucination that occurred in context to a dose of mRNA-1273.222 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding medical history and treatment details. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 57-years-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) Hallucination that occurred in context to a dose of mRNA-1273.222 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding medical history and treatment details. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAY-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a 56 years old male patient. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX 23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. The patient sought unspecified medical attention. There was no lab diagnostic studies performed. It was reported that PNEUMOVAX 23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
hot rash; Chills; Fever; Fatigue; rash from shoulder to elbow; rash on arm; itchy rash on arm; redness; soreness; A spontaneous report was received from a consumer concerning a 88-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, soreness, rash on arm, itchy rash on arm, hot rash, swollen rash, chills, fever, fatigue, rash from shoulder to elbow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A or MRN4544) intramuscularly for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the event(s) redness, soreness. On 8 Feb 2021, the patient experienced the event(s) rash on arm, itchy rash on arm. On an unknown date, the patient experienced the event(s) hot rash, swollen rash, chills, fever, fatigue. On 14 Feb 2021, the patient experienced the event(s) rash from shoulder to elbow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness, soreness, rash on arm, itchy rash on arm, hot rash, swollen rash, chills, fever, fatigue, rash from shoulder to elbow was unknown.
The pt broke out with chicken pox on 2/5/01 with approximately 100 spots. The pt was afebrile.