chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days after injection, pt. presented to clinic with generalized petechial rash and bruising. Labs demonstrated severe thrombocytopenia. Pt. was admitted for IVIG therapy. 12/7-12/8/2009 MD office visit for 11/12/and Admission H&P for 11/12/2009. Patient with c/o's "red dots" all over the body, sudden onset. Dx'd as idiopathic thrombocytopenia purpura, tx'd with IVIG
This was the first dose of Quadracel for the patient, but 4th doses of DTaP and IPV- patient previously received in Pentacel. On 7/11/19 injection site erythematous, swollen 3 inches in diameter, significant warmth, no drainage or fluctuance, no fever. Pt had history of cellulitis and staph so started on  Clindamycin. On 7/12/19 redness extended from day prior, swelling and pain decreased, no drainage or fever present. Pt completed antibiotic.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "EDS" (unspecified if ongoing); "POTS" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: strawberries" (unspecified if ongoing), notes: Known allergies: strawberries. The patient's concomitant medications were not reported. Past drug history included: Topamax, reaction(s): "Known allergies: topamax"; Edtas, reaction(s): "Known allergies: EDTAs". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 01Apr2023, she received Paxlovid for Treatment of COVID-19 and stopped on 06Apr2023. Vaccine administration time was reported as 02:30 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2 and the reported events covid-19, drug ineffective cannot be excluded.
Patient with 2 doses of Moderna, with last dose on 07/21/21.  Admitted through ED after nose bleed and seizures at home (testing positive for COVID on 01/08/22).  Patient continued to decompensate and died on 01/11/22.  Provider discharge note below.  "74 yo female, with PMH significant for COPD, CAD, hx of CVA, HLD, HTN and seizures, who presented to ED 1/10 via EMS for a nasal bleed. Hx obtained from ED staff, as pt was intubated, sedated and family was  not present. Pt had reportedly tested positive for COVID a few days ago and was noted to have a nasal bleed 5 days prior to presentation. EMS was called on 1/10 due to nasal bleed. Upon arrival, pt had two witnessed seizures. She was brought to the ED, where she was minimally responsive and having desaturations into the 80s. Decision was made to intubate. There was concern for a possible seizure in the ED due to pt having nystagmus and pt was given ativan. CT head and CTA were ordered. Pulmonary CTA was negative for pulmonary embolism but showed moderate pulmonary emphysema and moderate nonspecific airspace disease with features of bronchitis and bronchiolitis. Head CT showed no acute intracranial abnormality to the limits of noncontrast CT technique with layering fluid in the left nasal cavity and nasopharynx and within the left-sided paranasal sinuses. She was started on Zosyn and admitted to ICU for further care.    ED staff had long discussion with family regarding code status and family remained full code time of  admission to ICU. Overnight, she was noted to have a large dark liquid stool with blood.    1/11: UA was positive  for E. Coli. 1 of 2 blood cultures was suggestive  of coagulase negative staph. Her MAP dropped to 57 and the patient was escalated three pressor therapy with levophed,  vasopressin, and phenylephrine with minimal response. The attending physician, Dr.  had discussions with family this AM regarding worsening condition. Patient was unable to maintain O2 on maximum ventilator support. No other reversible etiology identified other than underlying lung injury. Multiple attempts at bagging without improvement. CXR without pneumothorax. Also on 3 pressors, maximum dosing in shock with hypotension. After discussion with family by my attending, family ultimately chose comfort measures and no further escalation of care.    Resident was called to bedside by nursing stating the patient had no pulse. Patient was  evaluated, no pulse or heart sounds were heard after one minute. She was cyanotic in appearance, cold in PEA. Given family's wishes to not escalate care and DNR comfort care status, called. "
pt recv vax & devel tiny bumpy, red rash on arms, legs & trunk; The rash resolved a wk later; MD did not know the name of the pt & could provide no addtl details;
-5 minutes after receiving the COVID-19 vaccine, the patient indicated that he was feeling light headed.  -The patient almost fainted, but his dad was there to catch him -The patient was asked to sit down, he was asked several questions and was responsive. -However, within a few mintues the patient seemed to go limp in one leg and was unable to move his mouth (paralysis of lips) - 911 was called -The patient was still responsive and kept indicating that he was ok. Within the next 5minutes, the patient seemed to cycle in and out of paralysis and being ok.  -The paramedics arrived, performed an EKQ and other test, everything came back normal -The patint denided transport to the ER and left the pharmacy
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines ROTATEQ (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Woke up 11/22/17 around 2am T-104.1. Shaking. Took MOTRIN. T-103.7 at 7am. Contacted family physician group-to take MOTRIN every 2 hours alternating with TYLENOL every 2 hours, MEDROL dose pack ordered. Same time in the day noticed that it felt like wrists were bound tight, but it went away. Later same evening, about 7pm felt more normal and much better. No further fevers.
just diagnosed with covid, breakthrough cases; covid pneumonia; kidney function was elevated a little bit; just diagnosed with covid, breakthrough cases; This is a spontaneous report from a contactable consumer or other non-health professional (wife reporting for her husband). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration in arm on 10Feb2021 in the morning as DOSE 2, single for COVID-19 immunisation (age at vaccination: 71-years-old). The patient medical history included: High blood pressure. The patient was also taking other products. The reporter mentioned that the patient was diagnosed with other unspecified conditions most of his life. No additional vaccine was administered on same date of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not report any AE (s) prior vaccination. The concomitant medications include Enalapril for blood pressure from an unspecified date at an unknown dose once a day by mouth. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration in upper left arm on 20Jan2021 in the morning as DOSE 1, single for COVID-19 immunisation. The symptoms started on 01Oct2021, and he was tested for covid on 06Oct2021, which came back positive and just got diagnosed with covid, breakthrough cases. On 01Oct2021 the patient had covid pneumonia and the patient was in hospital due to that since 12Oct2021 till the date of the report. Patient treatment included: He was on oxygen, steroids and antibiotics. He does not qualify for Remdesivir since his kidney function was elevated a little bit but has now returned to normal. The outcome of the events covid pneumonia and just diagnosed with covid, breakthrough cases (COVID-19)) was not resolved. The oxygen intake was improved but he was still on oxygen. The outcome of the event kidney function was elevated a little bit was resolved on an unspecified date. The outcome of the event just diagnosed with covid, breakthrough cases (Vaccination failure) was unknown.  No follow-up attempts are needed. No further information is expected.
cc: arm swelling HPI: 74 yo CAD HTN Patient came in w c/o swelling erythema on L deltoid in  region of prev moderna shot #2 given 3/12/2021.  no n/v/throat  swelling/f/c/abd pain/n/v PE: WDWN NAD, No increased wob L deltoid w circular erythema w central induration under small scabbed area w  increased heat t/o scab dry w/o discharge  AP: poss rxn to vaccine or secondary bacterial infection - try benadryl 25mg Q6-12h as tolerated, do not drive if taking - to ER if resp sxs - rtc for RN visit in 2 d for recheck
At time of injection pt had no issues. On day 3 it started to get red and swollen and painful. She came to pharmacy on day 4, where her whole upper arm was dark red with a bruise/greenish center that she said was hard underneath. She said it was still painful and hot to the touch. Sometimes it is itchy.
16SEP92 sore throat, flushed in PM 6PM t102-103 through Friday 18SEP92; 19SEP92 no temp 16SEP92 swollen gland rt to behind ear; 20SEP92 tired no temp cont lethargy through 22SEP92;
Patient was at front desk about to leave office profusely sweating, lips white. That was around 4:40 PM. Patient taken into room placed on table given water, benadryl.
pt recv vax 26FEB96 & & exp flu-like sx for a couple of days;pt recovered;
Pt exp a large localized redness measuring 14x5 cm which was noted on day 4 post immun accompanied w/mild tenderness;
Client reported that her left shoulder was extremely sore for two weeks after immunization given. She reported that she had never had this experience before.
01-23-16 fever q pm thru 01-27-16. 01-27-16 rash (circular, red, raised) on face, neck, trunk, extremities. 01-27-`6 went to MD given steroid.
Sore right arm, headache, extremely tired, dry mouth, thirsty, nausea, retching, vomiting, severe right thigh cramping, incontinence, lightheadedness, feeling as if I were going to pass out.
There were no adverse events observed. The child remained in the clinic approximately 30 min after the vaccines were given.
Patient developed sudden onset hallucinations (visual, possibly auditory) and psychosis beginning 6 hours after vaccination and lasting for 7 hours, then fell asleep. Reawakened with more hallucinations/psychosis 16 hours after vaccination (6 am today) lasting for another 1.5 hours. Transported to Pediatric ED where psychosis/hallucinations resolved. Examination normal. Remained at baseline (normal) upon discharge from ED.
He has lost a lot of  feeling and motor skills on his left side. he is dropping  lots of things and he cannot drink very well, things are falling out his mouth.
Breakthrough COVID infection 06/29/2022. Reports cough and lethargy. Unsure of onset of symptoms.
This case was reported by a consumer and described the occurrence of body achiness in an adult male pt who received hep B vaccine recombinant (Engerix B). The reporter is the pt. A physician or other health care professional has not verified this report. On 07Oct04, the pt received the first dose of Engerix B in the left arm. Approx 7 days following the admin of Engerix B, on 14Oct04, the pt experienced body achiness and fatigue. The events were ongoing at the time of initial reporting.
pt found bent over backwards off side of chair; eyes open, staring, bodys tiff arms drawn up, hands clenched w/tremors, unresponsive x 1 min; roused Bp 104/62, P76, pale, diaphoretic, incontinent urine, hot, felt sick, everything went black
swollen throat, arm, joint pain, dizzy, nausea, swollen neck etc.
Narrative: Presented to ER on 8/1/21 with low blood pressure concerns over 48 hours. Reported warmth and chills. Fever confirmed in ER. Noted patient was in in ER 3x earlier that week for other concerns not related to COVID infection. Dx with COVID Pneumonia. Admitted as in-patient and symptoms evolved to include fatigue, weakness, SOB, chest congestion, and cough. Treated with IV Remdesivir (08/02 - 08/06) and IV Dexamethasone 6 mg IV x 1 dose then po daily to complete 10 day course. Supportive care included ascorbic acid, zinc ,benzonatate, albuterol and supplemental O2. Discharged 8/6 with oral dexamethasone (tx end date: 8/2/21). Co-morbid conditions include HTN, BPH, T2DM,psoriasis (on apremilast), hx non-small cell lung cancer s/p chemo + radiation, gout, hyperlipidemia, obesity, non-obstructive renal calculi (right hydronephrosis s/p ureteral stent)
pt recv vax 1AUG96 & 3 days p/vax pt exp cramping & diarrhea;MD visit was required;MD r/o appendicitis;pt recovered;MD is not certain that sx are d/t vax & will examine pt & perform a GI eval;
Neck pain; Leg pain; headache; Initial information regarding this unsolicited valid non-serious case recieved from a Other Healthcare Professional (HCP) via Medical Information (Reference number- 00360303) on 16-Nov-2020.  This case involved a 16 year old female patient who experienced headache, neck pain and leg pain (Pain in extremity), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, two days after immunization, the patient's parents called the office reporting that patient was experiencing neck pain, headache and leg pain (Pain in extremity), but no fever (latency unknown). They declined to bring patient in to the office. The next day, they called again, reported that symptoms were ongoing. They again declined to bring patient to the office, but later brought her to an urgent care clinic. The staff at the urgent care clinic told them that the symptoms could be a reaction to the Menactra vaccine. Now the patient's parents are reticent to let her get the Fluzone Quadrivalent vaccine, because they believe that she will have another reaction. Reporter stated patient parent's were reluctant to allow her to get FLUZONE QUADRIVALENT because they believed she will have a reaction. As patient's parents reported an adverse reaction to a MENACTRA. Caller requested information regarding whether MENACTRA AND FLUZONE QUADRIVALENT had anything in common to cause same reaction. Patient had reaction to Menactra and questions safety of getting Flu.  HCP reported that the practice reported the Menactra Adverse Event at the time of occurrence.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.  There will be no information available on the batch number for this case.
Fevers started 12 hours post vaccine. Severe arm pain. Out of proportion to previous IM vaccines.
Monday morning I woke up with extreme pressure in my head. My blood pressure was super high. 165/145. I couldn't keep my blood pressure down. Intense pressure in my head and ears.
spasms, numbness in hands, body aches, temp-weakness, muscles hurt-pain in arm @ inj site;pain in hands & fingers woke pt up;
Dizziness, Arthralgia, Bruise at injection site and arm pain stiffness Narrative:
unspecified "titre test" was drawn on an patient which showed "negative titres for measles and varicella"; unspecified "titre test" was drawn on an patient which showed "negative titres for measles and varicella"; This spontaneous report was received from a nurse practitioner referring to a 29 years old female patient. The patient's drug reactions/allergies included penicillin, levofloxacin(LEVAQUIN) and hydrogen peroxide(PEROXYL). The patient's concomitant therapy included unspecified birth control pills.  On an unknown date at the age of 1 year and 3 weeks and at 4 years of age, the patient was vaccinated with the 1st and 2nd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis.  On an unspecified date in  May 2001 and February 2007, the patient was vaccinated with the 1st and 2nd dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis.    On 06-JUN-2019, an unspecified titre test was drawn on an the patient which showed negative titres for measles and varicella.   The patient sought medical attention but was not given treatment. It was unknown if the patient performed lab diagnostics/studies. The outcome of measles the events was reported as not recovered. The causality of the events was not provided.
75 year old female with PMHx of Alzheimer's dementia, T2DM, and CAD presented with generalized weakness, known to be COVID +. OA, labs revealed elevated troponins 0.07 -> 0.04 -> 0.07, EKG NSR with PVC. Cr 1.18, Lactic acid 2.1. D-Dimer >10,000. LE doppler neg for DVT.  UA positive. UCX showing multiple pathogens. CTPE and CXR WNL. ID consulted and Pt treated with 3 days of Decadron and 4 days of Rocephin for UTI. Recommended no more anti-COVID treatments as Pt. Was stable. Cardiology consulted given elevated troponins, likely due to demand ischemia, ACS unlikely. Treated with Decadron for three days. Saturating at 92% on Room Air. During her admission, Pt complained of right leg pain. X-rays showed acute intertrochanteric right hip fracture. Orthopedic surgery was consulted who took Pt back to the OR for intramedullary right hip nailing without complications. Pt Cleared from Ortho standpoint when medically stable. Pt was evaluated by PT/OT who recommended SAR. Only particular living site accepts COVID patients.   Patient's blood pressures fluctuated into 190s/100s during admission. Blood pressure meds were changed to include Lisinopril 40 mg daily and Amlodipine 10 mg daily. Patient is on Metoprolol 100 mg BID currently due to change in dose.
Sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm injection site). At the time of the report, VACCINATION SITE PAIN (Sore left arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication included steroids.  Treatment medication was not provided by the reporter.  The patient date of birth is reported 11-May-2021 as per source document.   This case was linked to MOD-2021-269994 (Patient Link).
Chilblains started in my right hand?s pointer finger off and on for 4-5 days. Would last 10 mins tops 4-5xs a day but today it is all of my fingers in that hand.
patient did not have an adverse reaction, he received a covid booster at age 15 and 9 months instead of 16 parents had attested and brought in form for the booster for the patient however it is not approved at that age yet.
Pt reported feeling hot and dizzy after getting his shot. He asked for water and we also gave him a cold pack. He sat for approx 20 minutes and every few minutes reported feeling better until he felt he was ok to leave.
Pt was diagnosed with Covid on 4/4/21. She had started feeling much better but was not back to baseline. She got the shot on 5/8/21 and about 8 hours later became severely ill back to the same level of illness as her initial diagnosis. She now has a return on hypoxia and her subjective lung function has significantly decreased which is worse than her initial course of illness. In conclusion, she had nearly recovered from covid and was made significantly worse after getting the vaccine 1 month after initial diagnosis.
Headache, Myalgia, Arthralgia, Fever, UrticariaPruritus, both doses with symptoms Narrative:
Developed severe itching, then hives, numbness of tongue and lips, feeling of swelling in throat, difficulty swallowing