chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A healthcare professional reported that a 44 year old female received an injection of Flu Shield in November 2002. Subsequently, she developed arthritis, joint pain, arthralgia, and hives. On 11/29/02, she was seen by a physician and a diagnosis of serum sickness was made. Treatment with Celebrex, Vicodin, and Allegra was started. On 12/2/02, she was seen by another physician who confirmed the diagnosis of serum sickness. Celebrex was discontinued and Zantac was added to her therapeutic regimen. No further info was available at the date of this report. This event is considered medically important (OMIC). Additional info was received on 1/13/03, from a physician provided revised symptoms, additional treatment medication, and event outcome. A healthcare professional reported that a 44 year old female received an injection of Flu-shield (2002-2003 Formula) in November 2002. Twenty-four hours post vaccination, she developed right eye swelling (almost swelled shut), which progressed to hives, chills, cough, and joint pain. On 11/29/02, she was seen by a physician and a diagnosis of serum sickness was made. Treatment with Celebrex,, Vicodin, and Allegra was started.On 12/2/02, she was seen by another physician who confirmed the diagnosis of serum sickness. Celebre was discontinued and Zantac was added to her therapeutic regimen. Her symptoms resolved gradually after a course of prednisone. She recovered. This event was considered medically important (OMIC).
All symptom occurred on the right side. Same side where the vaccine was given.  Mouth drooping, eye tearing and won't close, paralyses of the right side of the face in general
Joint swelling/ swelling in joints; Generalized aching/ Body aches; Fatigue; Joint pain; Pain in arm/ Arm was hurting; Fever; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Joint swelling/ swelling in joints), PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in arm/ Arm was hurting) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Joint swelling/ swelling in joints), PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (Pain in arm/ Arm was hurting), PYREXIA (Fever) and MYALGIA (Muscle ache). At the time of the report, JOINT SWELLING (Joint swelling/ swelling in joints), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in arm/ Arm was hurting) had resolved and PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Muscle ache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
wrists were sore/ had sores on legs/sores on crease of buttocks and back of head; Both wrists sore; Sores on legs/ a big round one on the front left leg and a big round one on the back right leg; Sores on back of head, crease of buttocks; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose bnt162b2 (Solution for injection; Lot number and expiry date was not reported; manufacturer: Unspecified) via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes first dose bnt162b2 on Mar2021 for Covid-19 immunisation. Patient stated that he received his vaccines in March and April. After he took the vaccines, he was having problems. Both of his wrists were sore on an unknown date in 2021. A week later he got out of the shower and noticed he had sores on his legs; a big round one on the front left leg and a big round one on the back right leg on an unknown date in 2021. He got sores on the back of his head and in the crease of his buttocks on an unknown date in 2021. He stated that he had an adverse ultrasound. Patient stated that he knew it had to do with the vaccine because he had not had any problems until a week or two after the vaccine. Stated that he has called to find out what he can do to get rid of this stuff; stated it was still going on since April. Patient mentioned that he goes through the clinic for healthcare. The patient underwent lab test which includes ultrasound with unknown results on an unknown date in 2021. The outcome of all the events was unknown. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
mom brought pt back 2 days post inj w/c/o firm, red, mass @ inj site; no fever, non tender @ this point
Vital noted, T-99.6, P-68, R-16, BP-130/68.  A&O x 3, Noted multiple erythematous based indurations over head, neck, torso, abdomen, both arms, and upper back.  Lesions somewhat tender to palpations and a small percent have white fluid-filled heads. Diagnosis: Generalized vaccinia and cherry angioma on right flank.   This is patient's primary vaccination.
There was confusion on his consent form.  He originally got J&J on 3-31-21 and Moderna booster on 10-22-21.  no adverse reactions outside of expected typical vaccine reactions
REDNESS, SWELLING, HEAT, PAIN STARTED 2 HOURS AFTER SHOT ON 4/16/21..PATIENT SAID IT WAS ABOUT A 6 INCH AREA. WHEN SHE CAME INTO CENTER ON 4/21/21 THE AREA WAS 2 INCHES AROUND INJECTION SITE, RED, WARM, TENDER AND HAS A NICKLE SIZED HARDENED AREA AT INJECTION SITE. DONOR DENIES ANY OTHER SYMPTOMS, HAS NOT BEEN FEBRILE.
Interchange of vaccine products; Feels a little dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna shot (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 23Oct2023, outcome "unknown", described as "Feels a little dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Oct2023, outcome "unknown".  Additional information: Just got it about 15 minutes ago. Previously had the Moderna, is all caught up with shots. Something happened, that kind of alarmed her. The drugstore seemed to think it was ok. Wants to be reassured. Usually, will ask to aspirate syringe so, blood doesn't get back in. Did not ask this time, they put shot in, needle did not go back in to the apparatus, it is supposed to, was still out. She asked if she got the shot. They said yes, have to be careful because it is really sharp. Said, it didn't retract like it was supposed to. Had others, has not had this happen before. They put the needle hazard thing, needle was still sticking out. Was told, they think she got the shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
My blood pressure immediately spiked. My whole body felt tingly, warm and I felt light headed. The nurses kept me there and monitored me for almost an hour.  I did not want to go to the hospital. The week after I kept calling my primary doctor saying I didn't feel well. Even though my Primary doctor originally told me not to get the vaccine, and I went against him and got it to make it easier to travel for me. I had the antibodies because my family and I had covid in the beginning on March 2020 very badly. My doctor kept disregarding my chest pains and left arm pains and numbing sensation. I ended up admitting myself to ER 3 weeks later. And I was instructed to follow up with a cardiologist.
Fever - feeling of Malaise - began 24 hours after administration of vaccine.  Responded to Tylenol.
pt recv vax 28JUL97 & 31JUL97 pt devel pustules w/a whit to clear center on legs, as well as one on back;pt was examined in office & it was determined that pt was was not related to vax w/varicella vax;
ACTHIB given on 5/18 at 1402. Patient started to have severe apnea, periodic breathing, desaturations & bradycardic events (at 1925). Required (PPV) positive pressure ventilation & was placed on a high flow nasal cannula. Infant made NPO & a septic work up done. The next day 5/19 at noon was able to remove NC & resume feedings. No reaction after the 5/21 PEDIARIX immunization.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (manufacturer unknown) that was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine was exposed to the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes and -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions. Digital Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA008347:
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 09-FEB-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly, lot # L048848 with expiration date 09-AUG-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005482:
Patient reports developing a metallic taste after receiving the vaccine.  States it lasted several days then went away.
TINNITUS!! Sudden, severe, tinnitus. Three weeks later, it's only gotten worse
Flu vaccine given left arm very close to shoulder joint. 3 hours after vaccine I had severe pain with movement of arm. All pain in shoulder joint. No relief with Acetaminophen. Significant relief with migraine medicine fioricet. 2 weeks later pain continues though not as severe. Difficulty sleeping on left side due to pain. Pharmacy where shot was given notified. Treating with ice/heat and exercise. Pain on movement only.
One I got my initial shot on 3/23/21 I had a metal/chemical taste in my mouth that went away in about an hour. After I received my 2nd shot on 4/13/21, I have had the same metal/chemical smell and taste since and it it more noticable on certain drinks and foods. Also my urine has this strong smell and dark and cloudy.
Swelling at sites of mosquito bites shortly after second dose of vaccine.  Images available; This is a spontaneous report from a contactable health care professional.  A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 03Apr2021 at 14:45 (at the age of 73-years-old) as a single dose for COVID-19immunisation. The patient did not have any relevant medical history.  The patient had no known allergies to any medications, food or other products. The patient did not receive any other medications in two 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 did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 shortly after the second dose of vaccine, the patient experienced swelling at sites of mosquito bites. The patient also stated that the images are available for the same. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event swelling at sites of mosquito bites shortly after second dose of vaccine was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had swollen arm. I have body aches in my back and arms. I spent 18 hours in bed. Then, in Nov, I went for some blood work because I have been extreme fatigue. The blood work showed that my ferritin levels was 8 times more than normal. My alt values was 10 times as high.
My entire body felt like I had been hit by a macktruck! almost 6 months later I still have bad pain in left buttock; fatigue has been unending, cold sweats then hot, hot, hot; could not think straight and am still having a lot of difficulty with any math: adding sabtracting, multiplying, fractions, etal. I felt that I would never be back to normal! I spoke to employee at pharmacy & she contacted GlaxoSmith, Klein Employee also spoke a longtime to others at GSK! It turned out, employee was told that in the very beginning of making this vaccine, a chemical, FORMALDEHYDE was used. I am horribly allegic to Formaldehyde!!! (see #10, attached.) The original paperwork given to me on Feb. 22, 2020, does not mention this chemical; and when I went to talk with employee after I became so sick, she looked at the paperwork that came with their shipment of the vaccine from their supplier, again no mention of Formaldehyde. I feel very happy that I didn't go into "Anaphiltric shock" from the vaccine. I went first to Dr. she referred me to pharmacy
Pt. waited in administration room for approximately 5 minutes after administration because of history of dizziness following another vaccine.  after she left room and walked down hallway she fainted.  She was unconscious very briefly.  She was  fully recovered after resting for 15 minutes and drinking juice
Syncope, code blue Code team called 12/12/06 Received medical records from hospital which reveal patient admitted 10/19/06-10/24/06.  Received flu shot on 10/20.  Patient experienced syncope, unresponsiveness, bradycardia & hypotension approx 1 hours later.  Cardio consult done.   Hospital course complicated by hypotension secondary to meds & by UTI. Final Dx: syncope secondary to sick sinus syndrome s/p pacemaker on 10/20/06 for AV block; coronary artery disease; HTN; high cholesterol; anemia; ;hypothyroidism; UTI; and SIADH.
HEADACHE; EXTREME CHILLS; VIOLENT SHAKING; FEVER; STIFFNESS/PAIN BACK OF NECK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: not reported expiry: not reported) dose was not reported, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced headache,extreme chills ,violent shaking, fever and stiffness/pain back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, extreme chills, violent shaking, fever, and stiffness/pain back of neck. This report was non-serious.  Version (1) created to amend previously reported information on 06-Mar-2021. Upon review the following information was amended: Labeling of event (headache) updated to labeled from unlabeled in CCDS and ,Labeling of event (fever) updated to labeled from unlabeled in CCDS and CCDS labeling for event chills was updated from unlabeled to labeled.
Case number PHEH2016US023720, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to a 42 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5ml intramuscularly on 12 Sep 2016. It was reported that, 8 patients received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this administration error (expired product administered). The case was assessed as non serious by the medical assistant.
Dr. called (pt's PCP) to report reaction that was reported to her by pt's sitter and husband.   States pt would not eat and was lethargic the night after receiving the vaccine. The next morning pt was extremely fatigued and "not acting like herself." By Tuesday night, pt was experiencing rapid breathing, sweating, and was very agitated. PCP states sitter reported that she heard "rattling" in pt's chest. Pt short of breath this morning with heart rate of 123. Pt will not eat or drink and is very weak. Pt has not been communicating with them like she normally does. Can only walk a few steps before having to rest. Pt was on her way to ED when PCP called to report this.
high pitched persistent crying & t105 4-6hr p/vax x 30hr;devel large local rxn @ HDTP site (red, swollen, tender);had jerking movements of extremities -spasmodic; global devel delay;pt stopped speaking consonants & stopped saying mom
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
Received VARIVAX and within 10 minutes began having symptoms of erythema to face, neck and upper body, severe dizziness, itchng, and "feeling like I'm on fire". Treated in ER with IV Benadryl and steroid. Discharged to home.
Seizure (tonic positioning) lasting approx 3-5 seconds, followed by intense middle abdomen pain, causing vomiting x1.
(L) arm triangular in shape 3x3.5cm hyperemia surrounded by slight reddish area 12x12cm. No warmth, no pain, no itching, no swelling. Treatment: Zithromax 280mg PO on day 1 and 140 mg po one day for 4 days.
Patient is 15 years old. Was enrolled in a mass vaccination clinic by health department. Patient age was not noticed by pharmacist, and vaccine was given. Age was noticed later in the evening at processing pharmacy. Patient's mother, was contacted by me on 2/25/21 to inform her that the shot was not indicated for patient. She reported that patient was showing no symptoms, and would contact me if that changed. I informed her that patient is not eligible for dose 2.
Per Patients wife, patient experienced Hives throughout all body, labored breathing and black feet. Patient was admitted in the hospital and given steroids. Patient went back to ER on 01/01/22 and administered Decadron shot and was discharged. Patient has a new Epipen prescription. Still has complaints of labored breathing and hives.
Client vaccinated with Moderna vaccines x 2 for Covid in October 2021.  Tested positive with rapid test on 12/24 but asymptomatic. Tested due to household exposure.
pt attended immun clinic on 12MAY93; 13MAY93 around 3AM pt had fever of 103.9, given APAP went down to 101.7 then Sat went up to 104.3; seen by MD s/s fever, dec appetite, vomiting, sleepy, no swelling of arm
terrible rash on back of his knees and on his back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (terrible rash on back of his knees and on his back) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (terrible rash on back of his knees and on his back). At the time of the report, RASH (terrible rash on back of his knees and on his back) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-200350 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Event onset date was updated.
Rash all over body; extensive itching; inflammation; still extant after 72 hours
Itching, red, swollen at local site. Diphenhydramine 50 mg PRN.
Severe muscle pain in both upper arms, more in the biceps than the triceps. Also, base of the neck pain and knee pain in both knees. This pain was only somewhat alleviated with Naproxen and or acetaminophen for a month and half. In November, I went to my Dr.. I had a CRP of 71.40 mg/L (normal is 0-2.99). Sedimentation rate was 61 mm/hr (normal is 1 - 20 mm/hr). Dr. put me on 40 mg prednisone for 5 days and the symptoms went away. They came back after the 5 days. I have since been on Prednisone, tapering down to find the smallest effective dose.
Patient had a large sized red patchy rash around injection site after receiving the vaccine.  Came in to report to me the day after receiving.  Also stated his nose was running non-stop, he felt weak, muscles ached, and was extremely sweaty.  He stated he felt feverish.  I contacted the patient today 07/14/19 at 3:00 PM and was still feeling lethargic and still has runny nose.  The rash on his arm around the injection site is still slightly red (slightly less in color from day before )and has not gotten worse or spread.