chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 hours after receiving vaccines infant ran temp up to 102, lethargic and less responsive. Dad reports depression type symptoms lasting one week, states lake a zombie then resolved. Dad states he did this after first DTap which infant received 03/21/2017, but this was not reported.
Pt reported arm swelling and "bruise" where she received influenza vaccination (at 3:58 PM 9/16/09).  Firm swelling 1" diameter) surrounding arm site that is affected.  (Approx 12". below site arm diameter is 11").  Hematoma present @ injection site 1" in diameter.  Able to move arm.  Returned 24 hours later 9/17.  No change in condition.  Ecchymotic changes present with Hematoma.  Referred to Primary Care MD.  Pt refused.  She consulted with her son who is a DPM.  No treatment required.
sick; Initial information received on 20-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves female patient of unknown who was sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (strength, formulation, route, frequency, batch and expiry date was unknown) produced by unknown manufacturer  via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
On 9/1/00 pt presented with lethargy but was active and playful in the office. Physical exam was unremarkable and was given a Prevnar vaccine IM in right thigh. About 1 hour, post vax, pt developed several wheal-like lesions on left thigh. Resolved after 1 hour. No other symptoms.
nervous; back started to itch/There was irritation; back felt itchy; back felt itchy and pinkish red/back was red; Arm soreness; This is a spontaneous report from a contactable consumer (patient) via a Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history included steel rods in back from 2006 and ongoing. The patient's concomitant medications were not reported. The patient was vaccinated and felt fine. She experienced arm soreness on 20Jan2021 originally. Then today, it was so bizarre, about an hour and a half ago, her back started to itch on 22Jan2021. There was irritation. She checked in the mirror, and her back was red on 22Jan2021. She was wondering if this was a reaction from the vaccine. She was getting nervous. A medical student gave her the vaccine. She didn't have a prescribing doctor. Twenty minutes after getting the vaccine, she noticed the arm soreness. It was worse yesterday, but today she thinks it is the same or maybe a little better. The irritation on her back seems a little better since she first noticed it. The outcome of the events back felt itchy and pinkish red and irritation was recovering. The outcome of the event arm soreness was not recovered. The outcome of the event nervous was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Positive, notes: Rebound after taking full course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. If vaccine received: Yes, other medication in 2weeks: No. On 27Nov2022 patient received Paxlovid for COVID 19 treatment till 03Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 18-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # N002204 with expiration date on 19-JAN-2019 (dose and route of administration were not reported). There was no adverse effect reported. The administered dose of the vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 2 hours and a previous excursion of 6 to 14 degrees Fahrenheit for 7 hours and 36 minutes. Data logger was involved in recording of the temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010661.
The patient experienced "excruciating pain and can't move his arm."; The patient experienced "excruciating pain and can't move his arm."; This spontaneous report was received from a pharmacist concerning a 70 year old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 03-SEP-2019, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular, lot # S004548, expiration date 12-AUG-2020 for vaccination (strength, dose and frequency were not reported). On the same date, he experienced excruciating pain and couldn't move his arm (movement disorder).  The outcome of pain and movement disorder was reported as not recovered. The causal relationship between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
pt developed bad headache and eye socket pain 1 hour after 2nd moderna -- a few hours later felt weak and diff walking / slower walking - woke next AM and could not stand or walk without assistance
Aches, chills, general fever symptoms (but without elevated temperature) lasting about 24 hours, starting about 12 hours after vaccine.
Patient developed rash with onset of Saturday 5/19 in the morning before 8AM.  The spots looked like mosquito bites and were itchy. Then on Sunday 5/20 he had more and some turned into blisters.  That same night he had chills, vomiting, body aches. On 5/21 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinicaly with varicella on 5/20 at a local urgent care.
Pt developed an erythematous, slightly raised, warm area, 7x11 cm, at injection site. Treated with BENADRYL PO and ice.
Initial case received on 10 October 2014 from a healthcare professional. A 22 year old male patient was vaccinated intramuscularly with FLUZONE on 09 October 2014 into the right deltoid, batch number UI198AA. Twenty minutes after vaccination, the patient experienced shortness of breath, heart palpitations and flushing. The patient went to the urgent care clinic and was treated with EPIPEN, BENADRYL and steroids. The patient was transferred by ambulance to the emergency department where he was treated with unspecified fluids. The symptoms waned and the patient requested to leave before being evaluated and left the hospital at 9:00 PM on 09 October 2014 which was 4 hours and 40 minutes after receiving FLUZONE vaccine. The patient reported on 10 October 2014 that the previous symptoms have resolved but he has tingling in his arms. The patient had no known allergies and was not ill at the time of vaccination. Concomitant medications and laboratory tests were not reported. The patient outcome is unknown. Documents held by sender: None.
SWELLING, REDNESS INCREASING DAY BY DAY, ITCHINESS, LOSS OF FEEL, HOT
Adverse event involved unexpected menstrual symptoms that triggered a severe premenstrual dysphoric disorder episode, which started on September 12th and lasted until the evening of September 15th. I experienced uncontrollable mood swings and irritability, followed by menstrual spotting, fatigue, and depression. My therapist was at hand during the peak of the episode, and paged in her supervisor and also notified my GP; I ended up missing two days of work and am still not at my best. PMDD is a known issue for me, but having it triggered so intensely by the booster was unexpected.
Very red, hot, swelling 4 days. Cold compress and Ibuprofen.
cough; tight chest; large amount of post-nasal drainage; sinus congestion; extreme fatigue; slightly elevated temp; feeling like I was developing a cold; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:45 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic sinusitis, chronic venous insufficiency. Allergies to medications, food, or other products: Ibuprofen (sensitive). Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; medroxyprogesterone (MEDROXYPROGESTERONE) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient received these medications including multivita within 2 weeks of vaccination. The patient did not receive 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 has not been tested for COVID-19. Since 04Feb2021 05:45am, morning following vaccine administration, the patient had a cough, tight chest, large amount of post-nasal drainage, sinus congestion, extreme fatigue, slightly elevated temp - feeling like she was developing a cold. She had previously been diagnosed with and treated for chronic sinusitis. No treatment received for the adverse event. The events were assessed as non-serious. Outcome of the events was recovering.
Burning foot; pain in her arm; Nausea; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date). Concurrent medical conditions included herpes virus infection.   On 10th June 2019, the patient received the 2nd dose of Shingrix. On 11th June 2019, 1 days after receiving Shingrix, the patient experienced nausea. On 12th June 2019, the patient experienced headache. In June 2019, the patient experienced pain in arm and burning foot. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, nausea, headache and burning foot were recovered/resolved.   It was unknown if the reporter considered the pain in arm, nausea, headache and burning foot to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in her arm, but not as much, but also felt very nauseous and had a terrible headache. The symptoms lasted about 4 days before resolving. The patient had the burning sensation in her feet. The patient state that it was not as bad and did not last as long as after the 1st dose. The burning was sporadic and tended to happen after exercising or walking around a lot. The patient did not consent to follow up. This case has been linked with US2019115024, reported by the same reporter.
Pt. felt like his mouth was scalded by something hot. When he looked in his mouth, there were many white bumps all over inside his mouth. Soon after, felt like he had hair caught in his throat that he could not get rid of. As of today, the bumps are gone and the hair in the throat feeling is much less.
approx 3hr p/vax, pt exp pain, swelling, & erythema at inject site; 3 days p/vax, pt had fever of 105f & was hosp for 1 1/2 weeks.Annual follow-up dated 11/27/00 provided no additional data.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypertension-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Sore back, debilitating.  Mostly between and below shoulder blades .  No neck pain. No paint at waist.  Also fatigue.
Near syncope and multiple seizure with multiple episodes of vomiting. 911 alerted - pt released to mother, transport refused - released to parent.
Extreme chills 6-7 hours after vaccine.  No appetite and dull, constant headache.  Fever as high as 102.  Armpit side closest to breast on right shoulder where shot given swollen for 30 hours after shot.  Majority of adverse effects lasted for 18 hours.  Two Ibuprofen taken every 6 hours.  Completely back to normal 44 hours from time of shot.
About 3 weeks after the 2nd injection,  I developed lateral epicondylitis pain in my left arm (note, I am right handed).   Then the following 3 weeks I also had pain in my distal left thumb joint.  As of this moment, I am only 70% recovered for both pains.  My doctor has now referred me to a physical therapist.
I was having some unusual side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I was having some unusual side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (I was having some unusual side effects). At the time of the report, ADVERSE EVENT (I was having some unusual side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded.
Pt. reported fever 100 degrees and sleepiness x 1 day. Inj. site was not tender or red.
This spontaneous report was received from a licensed practical nurse and refers to multiple patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of VAQTA lot # L023936 with expiration date 15-MAR-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Stroke occurred on March 5, 2021 with immediate loss of use of right arm......
Patient is a 82 y.o. female patient of DO with history of hypertension hyperlipidemia, A. fib presented to a local Hospital with shortness of breath A. fib with RVR    Acute on chronic hypoxemic/hypercarbic respiratory failure  Community-acquired pneumonia ABG at the time presentation, PCO2 of 97, repeat ABG today, PCO2 58 with normal pH Abx dced on discharge. Patient was initially on BiPAP, as patient is DNR CC now, will hold off on BiPAP.   Acute on chronic diastolic heart failure Pulmonary hypertension moderate RVSP 57 proBNP 17,000 at time presentation Echocardiogram July 2022, EF 70%, severe aortic stenosis Monitor renal function closely given concomitant severe aortic stenosis   A-fib with RVR Continue with p.o. amiodarone, p.o. metoprolol Continue Xarelto   Encephalopathy, likely metabolic, improving CT head no acute intracranial abnormality Normal ammonia Likely secondary to respiratory acidosis   Acute kidney injury,  Monitor renal function daily Consider transition to p.o. Lasix   Moderate to severe aortic stenosis Echo in August reviewed?EF 70%.  Diastolic function indeterminate. Functionally bicuspid AV.  There is moderate to severe aortic valve stenosis, V-max 3.3 m/s, mean gradient 27 mmHg, AVA by continuity 1.0 cm2, dimensionless index 0.32, planimetry 1.0 cm2 Diuresis as above   Goals of care: Patient was listed as DNR CCA and DNI, patient has been on BiPAP for 2 days.  Patient remains in A-fib with RVR.  Goals of care discussed with patient, patient upon entering the room states that she does not want to live and wants to die and be comfortable.  Also discussed with patient's son over the phone regarding patient services and son agrees that those were her wishes and patient should be transitioned to DNR CC and hospice has been consulted. Patient is being discharged to hospice.
diffuse hives devel approx 1sk s/p TD/MMR, t97.6;
The following morning, I experienced a slight fever (99.1), mild headache, and pain to the touch at the injection site.  These lasted only one day.
FROM MY HOSPITAL NOTES: Patient is a 61 year old female without significant past medical history aside from hypothyroidism who was admitted with new onset atrial fibrillation with rapid ventricular response.   She initially achieved good rate control with diltiazem, but is now spontaneously converted to normal sinus rhythm overnight.  She is remained in normal sinus rhythm throughout the day here, and has been up walking around the unit, but is been able to maintain sinus rhythm with this.  She currently is completely asymptomatic and denies any recurrent palpitations.  Throughout this event she has had no chest pain or dyspnea.  Her overall work-up has been negative thus far, with normal TSH, no evidence of acute changes on ECG, and negative troponins.  She completed a transthoracic echocardiogram that looked completely normal with normal left ventricular size and function.  She has normal cardiac valves.   A clear etiology of her atrial fibrillation has not been identified, however there is otherwise no evidence of other acute pathology, and work-up as above is been negative, also including a CT of the chest that was negative for pulmonary embolism.  She did recently have the second dose of her COVID-19 vaccination and had some fever and other systemic symptoms with this, and it could be possible that this somehow contributed.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG; TRESIBA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment Paxlovid. Therapeutic measure, Paxlovid,  was taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt returned to clinic 15FEB96 mom reported that pt had fever of 105 p/last vax 7DEC95;states pt given APAP 430PM  prior to vax fever, & screaming began 7PM;did given APAP;phoned MD but did not return call for 2hrs;9PM t102R & tired
Begining about midnight on Jan 1 I began becoming very sick feeling. Started with horrible mid stomach ache. Had feeling of chills with general malaise. No fever 98.7. but felt feverish. Vomiting, unable to even drink more than sip of H2O without gagging. Sweating profusely. Unable to stay awake for more than 15-30 minutes at a time. This lasted at least 24 hours. Now is day 2 and feeling much better generally but achy all over and sore injection arm. Still unable to eat solids am drinking fluids
Acute appendicitis approximately 10 days post vaccination.  Partially ruptured, surgery required.
Shot given on Friday 3/11/11 at approx. 5PM . Pt daughter-in-law called at 9:30 AM Sunday 3/13/11 - over night shot area become painful and fluid filled. Pt told to put cool compresses on it and take BENADRYL.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-370327 (Patient Link).