chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter was a consumer reporting on her grand niece who was a doctor and a professor. Reporter stated all of them had a low temperature of 97.2. She explained all of the family were low temperature and for some reason it hit them. She didn't want to get involved regarding this because she was a doctor and she took care of it. She didn't know anything else about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6 x 4" redness and induration at injection site . (-) for; mildly itchy, warm to touch.
Fever began day after vaccines. She then had vomiting and diarrhea on and off for 7-10 days. She came to see us 2 weeks later when she developed a rash. Fever lasted 3 days.
Patient states that she experienced localized arm pain and a rash shortly after receiving vaccination (8/30 - Monday). She works at a doctor's office and was told by that doctor that a localized rash is a normal reaction "COVID arm" and to not worry.  Towards the end of the week, the rash continued to grow. Her sister outlined the rash on Saturday and by Sunday morning it had continued to progress. She was seen at urgent care on Sunday, 9/5 and prescribed Clindamycin for a Cellulitis diagnosis. The treating doctor advised her to go to the ER to receive IVs if no improvement by Tuesday. At time of presentation at the pharmacy (9/5), the rash covered the majority of patient's right upper arm. Patient also complained of shooting nerve pain ("burning") that travels to her wrist.
Conj infection, edema, temporal aspect, OS. Cornea clear, fundi clear. Positive papilledema X 1 day.  Clear throughout OD.
5/8/13 (pm) fever 100-102.9. Chills, body aches, headache, cellulitis, redness and tenderness at injection site. Macular rash Tx = KEFLEX and TYLENOL.
Patient up to date on COVID vaccinations who admitted to hospital with COVID PCR and compications.  Provider d/c note:  "-year-old female with past medical history significant for seizure disorder and gout.  She presented to the emergency department on 08/06/2022 with a chief complaint of altered mentation.  She was diagnosed with COVID on arrival as well as pneumonia which was thought to be contributing to her symptoms.  She was started on COVID directed therapies as well as IV antibiotics.  Her stay was complicated by the development of shock for which she was in the intensive care unit with pressors.  Her stay was complicated by the development of paroxysmal AFib as well as bradycardia.  She was seen by cardiology team and had an echocardiogram which demonstrated normal ejection fraction.  She was placed on anticoagulation but did not require any rate control given her intermittent tachy/bradyarrhythmia.  She was also seen by EP during the course of her stay who did not recommend permanent pacemaker.  Her mentation and respiratory status continued to improve over the course of her stay and patient was weaned down to room air and CPAP with naps.  She will be discharged to a skilled nursing facility with plans to follow-up with her PCP as well as Cardiology."
get the flu; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves patient (unknown demographics) who got the flu (influenza) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Joint pain and aching. Sweating as if had a fever break. Lasted approximately two weeks.
Exacerbation of chronic graft versus host disease; Condition aggravated; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "Exacerbation of chronic graft versus host disease"; CONDITION AGGRAVATED (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug Comirnaty cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200613055 Same reporter/product/event, different patient;US-PFIZER INC-202200613056 Same reporter/product/event, different patient;US-PFIZER INC-202200613052 Same reporter/product/event, different patient;US-PFIZER INC-202200613051 Same reporter/product/event, different patient;US-PFIZER INC-202200613054 Same reporter/product/event, different patient;US-PFIZER INC-202200613050 Same reporter/product/event, different patient;US-PFIZER INC-202200613049 Same reporter/product/event, different patient;US-PFIZER INC-202200613053 Same reporter/product/event, different patient
No adverse effects reported; the patient, with birth date of 11/30/2018; received first dose of ROTATEQ/Initial Dose Received At A Later Than Recommended Age; This spontaneous report was received from a nurse and refers to a 4-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.    On 15-APR-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # R028191, expiration date 07-JUL-2020 for prophylaxis. No adverse effects were reported.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications and treatment information were not provided by reporter.The expired vaccine was administered to 37 patients( unknown amount of patients both males and females). On 08-Nov-2021, the vial was initially stored in the refrigerator. The vial didn't undergo temperature excursion.
"Sea legs" type feeling. Not really dizzy, but trouble walking straight,  weaving. Surreal type feeling. Lasted a few minutes then passed on its own. Only happened one time, fine now.
Pain with needle insertion. Sore arm. Red, raised, hot injection site. Approximately 8-9 hours later (after working) I noticed my entire left arm was inflamed, and slightly itchy. I had been itchy from metformin the days before my vaccination and stopped taking it the day of. Took a benadryl and went to sleep. Woke up SUPER itchy with small red dots (hives?) on my arms, chest, back, etc. Took tylenol for my arm pain. Took 2 benadryl for my itchiness. Had "chills" and slept 5 hours (12pm-5pm). Woke up still itchy but tolerable. Entire upper arm is sore up into my neck on left side. Arm is red from shoulder to wrist. Plan on going to walk in clinic tomorrow.
Had injection site swelling 3 hours after injection. Patient called us 2 days later to report symptoms. Patient came into office to have doctor examine reaction. Doctor prescribed Benadryl and drew circle on area on redness area and informed her if the redness goes outside the circle to call us to receive antibiotics. Reports area warm to the touch with redness.
Patient had sore arm, muscle aches and ran a fever of 103 degrees beginning this morning around 2 a.m.
injection was administered at about 7:00pm; symptoms began during the night... started feeling uncomfortable aches and pains, by early morning symptoms of fever, muscle aches, joint aches, overall pain and hypersensitivity,  nausea. Treatment - sleep; slept and drank fluids for about 24 hours  Fever reached about 102.2 on  4/2 at around 3:00am and broke shortly after that Continued sleep and fluids until about 10:30 on 4/2 Slowly regained energy and able to stay awake as usual from about noon on 4/2 onward. Slight weakness until 4/3. Strong headaches and aching  eyes on 4/3 and 4/4 4/5 - back to mostly normal
Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L029306, expiration date: 26-MAR-2017 (dose and route of administration were not reported). Administered doses of vaccine experienced temperature excursion of 48 degree Fahrenheit for 30 minutes, on unknown date. There was no previous temperature excursion. No adverse effects were reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Height fever, body pain, nausea, vomiting and headache, sleepiness and tiredness  starting 6 hours after vaccine, all those resolved after 2 days then Covid Arm,  Big red hot patch in arm, itchy and painful and inflammation, started 2 days after the 2nd dose of the vaccine
redness at the injection site; rash at the injection site; site was swollen like a big ball; itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy) in a female patient of an unknown age 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 INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.    Reporter did not allow further contact
felt awful; This case was reported by a consumer and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a dose of Shingles vaccine a few week ago and felt awful for 12 hours. The patient was so scared to get the 2nd one. The follow-up could not be possible as no contact details were available.
Tachycardia, hypertensive spike with dizziness lasting approximately one hour. Extreme nausea and acute headache lasting two hours after onset. Extreme fatigue lasting 4 hours with moderate headache and fatigue lasting into the night.
A 68-year-old female patient oriented in time and space refers to the EMT feeling dizzy 26 minutes after her second dose of MODERNA. At 10:56a.m. we proceed to take the s/v are: B/P. 240/100 mmHg, P. 72 beats/min. and Sat. 98%. She is transported to the Hospital at 11:40a.m.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; LOSARTAN; METFORMIN; SILDENAFIL; VITAMIN D NOS. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks.   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 currently available, a possible contributory role of the suspect drug to all the reported events drug ineffective, covid 19 cannot be completely excluded based on temporal association and known drug safety profile
I had very little reaction right after the vaccine but a few months later, I experienced chest pains for 4 days before I went into the hospital, before they determined I had extra fluid around the heart.
After approximately 1 hr after administration (IM) of TDAP and other injections I broke out in a "heat rash" like lesions over my elbows, knees, digital interspaces of feet and hands, groin, and underarms, as well as palms of hand, preceded by blisters (?) contact with rough clothing and car interior, (with exception of feet and hands). 7/1/2010 Follow up: 26 year old physician reported receipt of influenza (IM-Fluzone-Sanofi-Pasteur), H1N1 (IM-Sanofi-Pasteur) and BOOSTRIX (GSK) vaccines on 15 June 2010 with transfer to new command. Approximately 1-2 hours later he noted a prickly itching sensation with onset of "heat rash" to bilateral palms of hands and posterior elbows. The reddened areas to elbows were warm to touch. He had been touching black leather steering wheel cover and seat arm rest in his car (not new). Heat index at time in area was >100 degree's. There were scattered red mascules to posterior arm (upper/lower). This pruritic non-scaly red macular rash (heat rash) progressed over next 12-24 hours to include bilateral feet, groin, and posterior knees. He described any facial or chest lesions, oral lesions, or systemic symptoms such as headaches, fevers, nausea, vomiting, diarrhea, joint pain, or respiratory distress. he denied any target lesions. He did admit to mild myalgia which resolved within 24-48 hours. He did wear a new uniforma from new cleaners but advised no skin reactions with other uniforms cleaned at the same facility at same time. He denied any new detergents, deordorants, food groups, colognes, etc. He denied any recent illness but does work at a hospital. He self treated this "rash" with topical BENADRYL and colloidal oatmeal bath with relief of symptoms after 3 days. He admitted to difficulty sleeping x 3 days due to itchy feet. On day 13 96/28/2010) he was referred to Vaccine Healthcare Center by Immunization department of VAERS submission and concerns about possible diagnossi of Erythema Multiforme. Symptoms: Rash, oth nonspecific skin eruption(782.1).
Zoster vaccine administered instead of 2nd dose of varicella vaccine. Still watching for potential adverse outcomes.
Pt's husband called 15 minutes after administration commented that pt was having allergic reaction at the time and to fill her prednisone Rx and he would be picking up shortly. Spoke to husband 10/27 - pt. ended up in ICU.
At 1350 pt reported to feel cool, clammy, dizzy.  Pt sat down.  At 13:51 Laid client on cot, more alert, regained color not dizzy.  At 14:05 rechecked B/P sitting, BP 82/58, awake, not dizzy, talking, drinking water.  Skin warm, naturally dry.
19NOV96 awoke @ 230AM chills, fever, bitemporal h/a & joints aching, reddened warm, sl swollen area @ inj site;
Narrative:  Pt is a 97y.o. male who died on 03/10/2021 w/ h/o bradycardia, HTN, HLD, CAD, melanoma, occlusion & stenosis of carotid artery. Pt received Moderna Covid-19 Vaccination 2/2 on 02/03/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
COVID infection tested positive on 02/12/2022 fully vaccinated, recent hospitalization 1/31 -2/3 for HFrEF (37.5% EF) exacerbation, neurogenic bowel and bladder with colostomy d/t back injury from MVA at 14yo, left buttock pressure wound, PVD s/p left BKA, h/o recurrent spontaneous L PTX s/p VATS with mechanical and talc pleurodesis and history of tobacco abuse (36 pack year) who is presenting from home with dyspnea.  Symptoms began on 2/11 and included productive cough, chest congestion, shortness of breath, fatigue and fevers/chills. She had been doing well since her last admission and initially daughter was concerned that she had heart failure again but went to get tested for covid and that resulted positive on 2/12.
PT recd series of 3 Engerix-B vaxs (20mcg) on 17JAN90, 20FEB90, & 13JUL90; 30SEP90 test indicated PT was a low-responder;
Left Chest pain (Front & Back), Neck Pain to shoulder and chest (Left side), Chest tightness (Difficulty Breathing). I spoke to Doctor and she recommended me to go to the ED. X-ray, Blood work, (Chest) Ultrasound was performed and after that I was diagnosed with Costochondritis and was given lidocaine patches to suppress the pain. Up to this day (01/19/2022) I still experience the same symptoms. No improvement at all.
On evening of vax administration t103 a; 28JUL94 temp remained 103 ax; pt lethargic exp genl body tremors x 2 lasting 45-60 sec each; PMD notified high pitch cry; t100; lt leg also swelled-red;
Rec'd Tdap 1/7/13 at 10 a.m. Ret to work. 12:00 ate lunch. 12:30 - Felt lightheaded, flushed, nauseated "not right". Told to lie down. Sys BP >90. 1255 - felt "throat full & burning". Taken to ER. Also c/o some chest pain. Rx: BENADRYL & SOLU-MEDROL & IV fluid not much change. Approx 3:30 p.m. kept for overnite observation as cont. to complain of fullness & burning in throat. No SOB noted. Some mild chest discomfort.
I did not have an adverse reaction to the vaccine. I had to have a hamstring repair on my left leg and was in a brace for six weeks. In May 2022, I developed a blood clot in my left leg which was probably caused by the brace.  On July 5., 2022, I received my 2nd booster. We went on a trip on 07/22/2022 and arrived back home on 08/02/2022.  I felt very tired, and I tested for COVID-19 and it was negative. I had a follow-up appointment with my doctor for my surgery. I had some bloodwork and the IGG antibody was elevated. A few days later I noticed my right calf was swollen and contacted my doctor. I had an ultrasound, and I had a distal vein thrombosis in my right calf. I am currently on blood thinners.
pt recv vax 23JUL97 & 31JUL97 pt exp fever 103, pneumonia & pt hosp on 31JUL97;pt was placed on 02 during hosp & it was not discontinued until 6AUG97;
severe fever, nausea, vomiting, weakness 911 called, served, not taken to hospital zofran helped me stop vomiting fever lasted 2 days but lessened after 1 day
contracted Covid; This is a spontaneous report from a contactable consumer or other non hcp. An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 20Jan2021(at the age of 83-year-old) as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 23Jan2021 she contracted Covid from the skilled nursing facility she was in. She received Covid antibody therapy on 24Jan2021. Reporter wants to know when she can get the second dose of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Jan2021. Outcome of event was unknown.  Information on the lot/batch number has been requested.
When I got the 1st SHINGRIX vaccine, I got a few chicken pox-like blisters that quickly went away and I did not report it. The second dosage of the SHINGRIX vaccine on 4/23/19 caused a different reaction. At about 11:30 that evening, I began to feel like I was getting a fever, my teeth began to chatter, and I began to shake. I went to bed and got warmed up and went to sleep. Around 1 a.m. that morning, I woke up with the same symptoms. I took my temperature and it was only slightly elevated (99), but I took some EXTRA-STRENGTH TYLENOL and went back to sleep. I went to work but I felt a tiny bit all day as if I had a fever so I took two aspirin in the am and the pm. I am feeling much better, but there's still a bit of lingering body aches as if I had a very low-grade fever.
Pt c/o l. arm pain, not at rest, but when he raises his elbow above his shoulder.  Pt denied pain on palpation of muscle. Encouraged to seek PCP opinion.