chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at the injection site; Swollen fluid-filled nodule above collarbone; Chills; Body aches; Night sweats; Mental state was considerably negative/depressive; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included multivitamin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 16:00, the patient experienced rash at the injection site, a swollen fluid-filled nodule above collarbone, chills, body aches, night sweats for 3 nights and the patient's mental state was considerably negative/depressive. The patient stated negative/depressive mental state was unrelated to any circumstances other than the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash at the injection site, swollen fluid-filled nodule above collarbone, chills, body aches, night sweats and the mental state was considerably negative/depressive were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
No additional AEs reported.; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2022, 1 dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status recombinant human albumin (rHA)  0.5 milliliter, lot #U019287, expiration date: 15-DEC-2022, administered subcutaneously (anatomical location was not provided) was administered for the patient for prophylaxis. The vaccine experienced a temperature excursion of -12.3 degree Celsius for 1 hour (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
SENSTIVE SKIN; DIZZY; BRAIN FOG; SENSITIVE SKIN WHICH FELT ACHY; FLU LIKE SYMPTOMS/CHILLS/FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 10-MAR-2021, the subject experienced flu like symptoms/chills/fever. On 17-MAR-2021, the subject experienced senstive skin. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced brain fog. On 17-MAR-2021, the subject experienced sensitive skin which felt achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms/chills/fever, senstive skin, dizzy, brain fog and sensitive skin which felt achy was not reported. This report was non-serious.
Pt received 2nd dose of Pfizer CIOVID-19 vaccine today, 5/12/2021 and within 5 minutes reports lip and face swelling and throat tightness.  Pt denied any reactions from 1st dose of Pfizer COVID-19 vaccine, but report she has idiopathic anaphylaxis, an autoimmune disorder, chronic hives, asthma and she has anaphylactic episodes about once a month. Pt given 2 epi pen autoinjections in thigh in office prior to EMS arrival. Pt was transported in stable condition to  Hospital ER via EMS for further evaluation and monitoring.
No adverse events or reactions noted. Pt was given Pfizer monovalent covid vaccine instead of Pfizer bivalent booster. Pt left in stable condition.
Reports receiving Pfizer vaccine 080621 at approx. 0900 and by 1600 was experiencing severe joint and muscle pain. Evaluated at ER and found to have low potassium level. Discharged home and by Saturday 080721 she was experiencing nausea, vomiting, and diarrhea which has continued through Tuesday 081021.
This initial spontaneous case was received on 08-Nov-2017, from an consumer, concerning a 44-year-old, adult male patient. The patient's historical condition included small murmur in childhood, which was resolved. The patient's current condition included, unspecified mental disease disorder and the concomitant medications included EXCELL 300 mg, bupropion, escitalopram, clonazepam, estazolam, DEPAKOTE Extended release, TRIUMEQ, testosterone for unknown indications. On 04-Nov-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration, anatomical location batch number, expiry date). On the same day, within 2 minutes of vaccination, the patient's heart rate went up, had double vision, was unable to concentrate and felt like suffocating. The patient stayed for some time and drove home when he felt better. On 05-Nov-2017, the next day, when he woke up, was confused and really tired and had no energy. On the same day, the patient went to the hospital and there he collapsed on the floor and lost consciousness. The blood pressure was found to be 38, was hospitalised and kept under observation for 2 nights at cardiology department. The blood pressure was monitored and the physicians thought the BP would not raise above 50, hence insertion of pacemaker was considered. The patient underwent ECG (Electrocardiography), cardiogram, echogram, full blood panel, stress test for which result was not reported. The patient received unspecified medicines in the hospital. At the time of the discharge BP was found to be 75. At the time of the report, heart rate increased, double vision, unable to concentrate and suffocation was resolving and the outcome of other events was not reported. The reporter assessed the events as serious (hospitalization).
Developed a dry cough that persisted for several days, eventually developed bronchitis and chronic shortness of breath, dizziness, heart racing, fatigue, which continues,
I was hospitalized 2Xs immediately after receiving the 2nd Covid-19 vaccination for coronary artery blockages: 3/19 and again 3/22. I had been experiencing what I thought was heartburn and was referred to by PCP to a cardiologist who ordered a stress test that I passed. After suffering severe pain in my sternum from 11:00 pm 3/18-1:00 am 3/19 I went to the hospital. An EKG showed no coronary issues yet at 7 am I was taken to the cardiac catheter lab where it was discovered i had a 100% blockage. A stent was implanted and i was released around 4:30 pm the afternoon of 3/20. The morning of 3/22 I once again experienced severe chest pain and called an ambulance. I was told by the EMT my heart rate reached more than 200. I was rushed back to the same hospital where a 2nd cardiac catheter was performed. It was discovered that the stent implanted 48 hours earlier had a 100% blockage. It was opened and several additional stents were implanted. I was kept in the ICU for 2 days for observation and then released. No one I've spoken with since can verify what caused the 2nd episode. Several people at the hospital speculated the cause for the 2nd attack may have been a single dose of Brilinta that had been missed Saturday evening because by the time my wife got me home from the hospital and settled our pharmacy was closed. She picked up my prescriptions first thing Sunday morning and I took everything as directed. My cardiologist agreed with  me that missing 1 dose should not have caused such an adverse reaction.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 25-OCT-2018, the patient received a dose of improperly stored VARIVAX (lot # N029628, expiration date: 23-OCT-2019) (strength, dose, route and frequency were not provided) for prophylaxis. The sterile diluent stored properly in the refrigerator. No adverse effects were reported. The VARIVAX vaccine was exposed to a temperature excursion of 6 Fahrenheit (F) degrees to 14 F (11 F) for 1 hours and 9 minutes. The previous excursions was 6 F to 14 F for 49 hours and 16 minutes and 15 F to 46 F for 39 hours and 57 minutes. A digital data logger was involved.
During the night I had mild pain, and the arm area was a little warm. When I got up I could see that there was a pink, hard area next to where they gave me the Spikevax 2023/24 vaccine. Then I went to the Urgent Care where they prescribed antibiotic treatment (Clindamycin 300 MG).
they gave a patient expired (June 30, 2019) Fluzone Quadrivalent 0.5ml, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 91 years old male patient who received a0.5 ml dose of expired vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ005AC, expiry date: 30-Jun-2019 via intramuscular route in the deltoid NOS on 15-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Muscle pain; Cramping in legs; Cramping in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 03May2022 at 11:15 as dose 4 (booster), single (Lot number: FK9894) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Rotator cuff surgery", start date: 09Feb2022 (unspecified if ongoing), notes: Verbatim: Rotator cuff surgery, Rotator cuff surgery on 09Feb2022. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FJ1620, Location of injection: Arm Right), administration date: 23Nov2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 19Apr2021, when the patient was 61-year-old; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 04May2022 at 15:30, outcome "recovered", described as "Cramping in hands"; MUSCLE SPASMS (non-serious) with onset 04May2022 at 15:30, outcome "recovered", described as "Cramping in legs"; MYALGIA (non-serious) with onset 04May2022 at 15:30, outcome "recovered", described as "Muscle pain". Therapeutic measures were not taken as a result of myalgia, muscle spasms, muscle spasms.  Additional information: If other vaccine in four weeks: No No other vaccine was administered in four weeks. Prior to vaccination patient was not diagnosed with COVID and was not tested positive since vaccination.
Swollen supraclavicular lymph node on left side of neck, above collar bone; Also some mild pain, discomfort in groin area and underarms; Also some mild pain, discomfort in groin area and underarms; Also some mild pain, discomfort in groin area and underarms; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 30Mar2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hashimoto's disease, anxiety and gluten intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. On 06Apr2021, the patient experienced swollen supraclavicular lymph node on left side of neck, above collar bone and also had some mild pain, discomfort in groin area and underarms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen supraclavicular lymph node on left side of neck, above collar bone, some mild pain, discomfort in groin area and underarms was recovered on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 20Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Nausea, then itchy, tingly, bumps started popping up on neck about one hour after nausea. They continued to spread to my face, neck, chest, upper arms, upper back, and later under my breast. They never broke open, just itched and tingled for 5 full days. Completely gone after 8 days.
Started 5/05/21 with shortness of breath - increasing over the next 2 weeks with dyspnea on exertion  Congestive Heart Failure and Cardiomegaly
PATIENT HAD NO ADVERSE EVENTS, REQUIRING NO TREATMENT HOWEVER, PATIENT RECEIVED 2ND DOSE VACCINE ON THE 23RD DAY DUE TO INABILITY TO MAKE IT ON RECOMMENDED TIME FRAME BECAUSE OF WORK SCHEDULE.
Pain; Migraine headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 2022, outcome "unknown", described as "Migraine headache"; PAIN (non-serious) with onset 2022, outcome "unknown".  Additional Information: Patient had pain and suffering from the past year and a half for the migraine headache. Patient needed to speak to someone who could write a check for pain and suffering for the past year and a half with this migraine headache having.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8 days after the vaccine, i felt an itching in the shot area. I observed an oval shaped area about 4 inches long and two inches wide that was red and very warm. Under the skin it felt rather solid. In the past days I felt more tired that usual and have slept more.
Pt recvd vax & approx 1 day following vax got a needle stick & HBsAg was weaklly positive; No further details were provided;
Information has been received from a 17 year old female, for the pregnancy registry for GARDASIL, with asthma and VICODIN allergy, who in January 2008, was vaccinated with the first dose of GARDASIL. On 21-MAR-2008, the patient received the second dose of GARDASIL. Concomitant therapy included albuterol. The patient reported that on 25-MAR-2008, she found out she was pregnant. On an unspecified date, the patient had a pregnancy test that was positive. At the time of the report, the patient was 22 weeks and 4 days gestation. Her LMP was 15-FEB-2008 and EDD 21-NOV-2008. The patient sought medical attention. Follow-up information was received from a nurse who reported that on 17-NOV-2008, the patient had a cesarean section done because her baby was in a breech position. The patient reported the baby's weight at birth was 7 pounds and 13 oz. At the time of the report, the patient reported that she had a six month old "healthy and big" baby who weighed 20+pounds. The patient stated that the baby had asthma, and an inhaler, but that he was doing ok with that; and that the doctors were trying to figure that out, but did not know if he had allergies or not yet. At the time of the report the patient stated that she was feeling better from the cesarean section but still felt a little tender sometimes. Additional information has been requested.
pt stepped on nail;difficulty using arms d/t pain;3wk later extreme pain biceps couldn't comb hair or put on shirt-exercise helped (golf);pain;
Abdominal pain; This is a spontaneous report from a contactable consumer. Caller mentions both daughters had abdominal pain as well and they had the Pfizer COVID 19 vaccine too; they went first. This is a clone reports are created to document the second daughter's experience. This is report three of three. This consumer (patient's mother) reported for a 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Jul2021 (at the age of 19-year-old)(Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Caller reported that her daughter complained of abdominal pain, a week after the second dose (on an unspecified date in Aug2021); added she could not go to class. The patient had not visited to Emergency Room and Physician Office due to the event. The clinical outcome of the event was recovered on an unspecified date in Aug2021 (now she was completely recovered).  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Symptoms appeared 40 hours after receiving immunization. The area was the size of an egg, was bright red, hot, with some muscle soreness. It took seven days to resolve. The patient used ibuprofen for redness and pain and takes an allergy pill, claritin daily.
PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTION TO THE VACCINE. PATIENT HAD ALREADY RECIEVED BOOSTER SHOT AT PHARMACY. CAREGIVER AND PATIENT DID NOT MENTION THAT PATIENT HAD ALREADY RECEIVED BOOSTER SHOT ON 11/19/2021; PATIENT HAD RECEIVED 1ST DOSE 02/05/2021, AND 2ND DOSE 02/26/2021; THEREFORE A 4TH DOSE WAS GIVEN TO THE PATIENT ON 12/14/2021. PATIENT DID NOT HAVE AN UPDATED CDC CARD INDICATING BOOSTER SHOT WAS GIVEN.
red swelling that is warm to touch on site of arm that did not initially appear at time of injection, became noticeable to patient a couple days later
Evening of vaccination developed eternal pain felt to be heartburn. Fever, chills, aches, weakness and bladder spasms developed overnight. The following day fever resolved, headache began, sternal pain still lingering. After dinner  it escalated to an ER visit. Severe pain unrelieved by fentanyl or GI cocktail. Profuse sweating and pain, hypertension . Responded to toradol. Still painful along sternum, sore to touch. Slow gastric emptying? Feeling of fullness and tightness on day 3 still.  Injection site red, swollen and over several inches.  Cardiac or aortic events ruled out.
No adverse effect to patient, however, she had received a dose of the bivalent COVID vaccine on 10/26/22 and did not require a second dose as she has no immunocompromise.
arm pain swollen, red and itchy Narrative:  no issues until 8 days later swollen red itchy arm
Patient felt syncope/fainting. Onsite EMS was called vitals BP 104/66 BG 104  96% O2 HR 64. Patient treated and released against medical advise.
I was pretty sick for 2-1/2 days after my second shot.  then felt pretty normal for two weeks.  about 17 days after my last shot I began to get head aches, body aches, mild stomach ache and fatigue.   I have a steady temperature of 98.0  I do not have a sore throat or a runny nose.  although that is because of the Allegra.  sorry I forgot to include that in my meds list.   there has been no change or improvement so far.   I am in great physical and mental health prior to this.   very fit.    need motrin pills to cope and sleep.   what is most likely going on??
On 11/28/21, 12 days after receiving my booster shot, I woke up with my legs and back of my neck covered in hives -- red, raised, itchy bumps. I took Benadryl all day, woke up Monday 11/29 and they were worse, and also spreading to my trunk area. Went to Urgent Care on 11/29, they prescribed me a 5-day course of Prednisone and told me to follow up with my PCP if they hadn't cleared up in a couple days. They didn't, so I saw my PCP on 12/3/21. Was prescribed another round of Prednisone and told if it didn't clear up by mid next week, around 12/8/21, to call back and they'd get me in to see the dermatologist. They still hadn't cleared up but had changed -- now it's a flat, red rash/hive that randomly appears all over my body and burns and itches. It randomly flares and looks like I've been scratched by a cat or something. On 12/13/21, the dermatologist did a test where he took his pen cap and scratched me a few places around my body; within minutes, each scratch had turned into a large red welt. He told me I was clearly reacting to something, that these hives were not merely a result of stress. He said he thought it was the vaccine and gave me a reference for an allergist. I saw the allergist on 12/16/21, she put me on a strict food elimination diet for a few weeks to see if it was a food allergy and the hives have not cleared up at all. It is clearly not food and given that I've changed nothing about my routine, it's clear I AM having a reaction to my booster shot. After my first two doses of Moderna, I had no abnormal side effects but I'm worried about how long these hives might last. I haven't be able to work in over a month because of severe discomfort. Really hope the CDC can give us some guidance on how to deal with this. This link makes it clear quite a few people are dealing with this
Client experienced tingling and numbness along sides of tongue within 15 minutes of receiving vaccine. The sensation continued (but did not worsen) for about 3 hours after vaccination was given. No other symptoms.
pt recv vax MAR or MAY 1996;pt titers were negative;pt was exposed to chickenpox;
I have been suffering the pain long term, doing detoxing and healthy eating hoping fo clear out damage and toxins, nothing has helped and I?m still in pain. Had chiropractic work and need it regularly as muscles so locked up.