chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presents to ER with 10x10cm circular area to inner aspect (R) upper extremity, 2 1/2cm fluid filled blisters at 3 o'clock & 9 o'clock. Pt. states vaccine was definitely given in (R) arm.
p/vax pt devel itchiness, fever & approx 10 varicella like lesions over body;reporting MD felt that itchiness, fever,& varicella like skin lesions were not r/t vax;
Initial unsolicited report received from a non-healthcare professional (medical assistant) on 17 August 2015. A four-year-old female patient had received a fifth dose of DAPTACEL (manufacturer: Sanofi Pasteur LTD, batch number: C4780AA, expiration date: 23 July 2017, dose was not reported) intramuscularly in left deltoid, a fourth dose of IPOL (manufacturer: Sanofi Pasteur SA, batch number: L1001-1, expiration date: 14 July 2017, dose was not reported) subcutaneously in right triceps area on 13 August 2015. The patient also received a dose of PROQUAD (manufacturer: MSD, batch number: L014401, expiration date, dose and dose number were not reported) subcutaneously in left arm on 13 August 2015. Previously the patient received four doses of DAPTACEL and three dose of IPOL on an unspecified date. The patient did not have illness at the time of vaccination. The medical history and concomitant medication were not reported. On 13 August 2015, same day post vaccination, the patient experienced fever 102 (units not provided), chills, headache, body aches and temperature sensitivities for three days. On 17 August 2015, four days post vaccination, the patient developed hives around the injection site of DAPTACEL. Laboratory investigations were not performed. The patient received BENADRYL as a corrective treatment for local hives. The patient was advised to use ZYRTEC. On an unspecified date, the patient recovered from the events of fever, chills, headache, body aches and temperature sensitivities. The outcome of the event hives around the DAPTACEL injection site was unknown. Documents held by sender: none.
I experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and Lymphocytic Leukemia.
A nurse reported that an unidentified pt received Pnu-Imune 23 vaccine (pneumococcal vaccine polyvalent) and subsequently developed an injection site reaction characterized by redness, warmth and edema. No additional information was available as of the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Fast heart beats; Body temperature is 100 degree; Weak; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beats), BODY TEMPERATURE ABNORMAL (Body temperature is 100 degree) and ASTHENIA (Weak) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HEART RATE INCREASED (Fast heart beats), BODY TEMPERATURE ABNORMAL (Body temperature is 100 degree) and ASTHENIA (Weak). At the time of the report, HEART RATE INCREASED (Fast heart beats), BODY TEMPERATURE ABNORMAL (Body temperature is 100 degree) and ASTHENIA (Weak) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree.         No concomitant medicines were reported. No treatment information were reported.  Action taken with the drug in response to events was not applicable.
Day 1 (08/17): Shot given; Day 2: Sore, swollen, red arm (almost entire upper arm); Day 3: Parkinson's plus symptoms (legs not working) returned after not being apparent for a while; Day 4: Woken up with SEVERE pain in right foot/big toe (gout-like, but patient does not have gout); Day 5: Toe still red and swollen, but pain has started to lessen; Day 6: Foot pain almost gone.
deafened her for ten minutes; This is a spontaneous report from a contactable consumer patient. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient got the vaccine on an unspecified date and it deafened her for ten minutes. She was not sure if that was a side effect that she should be worried about. The patient recovered from the event on an unspecified date.   Information on the lot/batch number has been requested.
muscle and joint aches especially in the lower extremities, skin hurt, low grade fever, lethargy,  and fatigue... lasting 18 to 24 hours took ibuprofen and acitomeniphen intermitently to alleviate systems
high temperature reaching 99.7F, chills, slight nausea, sweats, dry mouth, followed by migraine. Wore socks to bed, increased fluid intake, and took 1-200mg ibuprofen around 5:00am. Symptoms mostly went away by the next morning.
Fever and chills (8:30pm-2:00am next day)  Nausea / vomiting (3-4am next day) Extreme back pain (mostly lower back) (2am-7am next day) Red, hot, itchy rash on left side of back / abdomen (I just noticed at 11pm day after, not sure when it began) Extreme fatigue and mental fogginess (8pm day of - still continuing 11pm day after)
Had local rxn to MMR; lightheaded; pain in area-ice applied to area; BP 84/48; p96; R16; erythematous, swollen lt arm to size of a small grapefruit, warm to touch; 215PM BP 98/64; P88 pt d/c to mom;
Generalized weakness with elevated D-dimer, ESR and CRP. Development of AI arthralgias. Resulted in hospitalization for further work-up.
Info has been received from a hospital physician concerning an adult female who was vaccinated with a dose of MMRII. It was noted that the physician was previewing a hospital policy of checking titers for immunity to childhood diseases, and she found one employee who was given a dose of MMRII and a booster, and had very low if not negative titer for rubeola. No medical attention was sought. There was no product quality complaint. No additional info is expected.
Arm was a little sore night of jan 11. Upon awakening day 8 (jan 12) arm had blotchy welt appearance at and around site of injection. Sore from swelling. Hot to touch (104.4 degrees) by the end of the day I felt as if I was wearing a blood pressure cuff. The next day it felt better and has since, but it continous to grow in appearance and now is a defined shape across span of my arm near injection site. Slightly warm and itchy on day 13 (jan 17)
Patient was diagnosed with Myocarditis/pericarditis due to a pericardial effusion and elevated troponins on 9/28/2022.
Fever to 101.8 x 3 days, myalgias diffuse; local increasing tenderness, redness and swelling at site, rigors, headache, anorexia.
Massive bruising at the injection site that is still there almost three weeks after vaccination. Other mysterious bruises on my other arm and now legs.
Patient states 1 week after receiving smallpox his and turned red and was swollen around the area. Patient directed to use warm compress and see Dr. if problem worsens.
Began with tiredness, trouble sleeping, weakness. then heart palpitation nearly blacking out. Breathing problems. Various severe momentary pains, different areas mainly left side of body. Then severe twitching in hand and leg, left side, lasting for hrs. Left me with tremors inside of body, numbness in leg and arm, temporary paralysis in 2 fingers, right side, etc, etc. Still am dealing with some of these symptoms although they are much less severe then they were. Still experiencing tics and tremors constantly though less in intensity, still tire easily.
no adverse event; inappropriate schedule of vaccine administration; This spontaneous report was received from a lawyer and refers to a 66-year-old female patient. On 05-JAN-2012, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. On 28-JAN-2013, she received another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On an unknown date in October 2015, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine). No adverse event was reported.  This is one of two reports referring to the same patient.; Sender's Comments:  US-009507513-1704USA009884:
fever 103 R in PM of 28FEB95; very irritable; stiff & shaking; mother gave APAP q 4 hrs; reports pt woke aprox q 4 hrs; reports pt woke approx q 4 hrs during noc & was given APAP; temp was taken only once but seemed to come down; pt ok
Information has been received from a physician concerning a 56 year old female patient who on 10-SEP-2009, was vaccinated with a dose of PNEUMOVAX 23 (Lot# 663888/0627Y). Concomitant therapy included steroids. On 14-SEP-2009, the patient developed swelling at the injection site, fever and body aches. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Follow up information has been received from a health care professional concerning a 56 year old female patient who on 10-SEP-2009, was vaccinated with a dose of PNEUMOVAX 23 (Lot# 663888/0627Y). On an unspecified date, the patient developed swelling, fever and body aches. The patient went to the office on 14-OCT-2010 and she received her steroids (unspecified). At the time of the report the patient present status was unknown. This is one of the cases received from same source. Additional information has been requested.
Patient currently an inpatient at (4) days   H& P:Pt is a 91 y.o. female who presents today with vague complaint of weakness and AMS. She is found to have a UTI, as well as Covid (+) with small right basilar airspace density. She is admitted for sepsis due to UTI, with comorbid AKI on CKD, hypothyroidism, HFpEF, atrial fibrillation on Coumadin. Her INR is supratherapeutic >8. Later in ED course, she is found to be profoundly bradycardic and hypothermic; she is given Ca gluconate, IV levothyroxine with some improvement. She is given warmed fluids and started on Bair Hugger. Her alertness improves somewhat, and her HR improves into 50-60's. She is made DNR per discussion with son over phone; he is planning to see her tomorrow.   ASSESSMENT / PLAN: Pneumonia due to COVID-19 virus Assessment & Plan -Initially normoxic, however becomes hypoxic later in evening -Renal function precludes Remdesivir -Start supportive care, steroids -Sats maintained on NC, but she breaths through mouth, so changed to NRB   Hyperkalemia Assessment & Plan -at 5.8, without T wave peaking or QRS widening -Could be cause of bradycardia -Still 5.8 after fluids; give 20mg Lasix IV x1   * Sepsis due to urinary tract infection Assessment & Plan -Culture collected 12/8 pan-susceptible E. Coli -Treat with Rocephin -She is hypothermic to 91F and bradycardic into 30's; unclear if sepsis is cause   Right frontal lobe lesion Assessment & Plan -Area of questionable edema right frontal lboe -I speak with Dr. of neurology who advises MRA and MRI w/ and w/out -This is deferred as she becomes bradycardic later in course    Acute renal failure superimposed on stage 3a chronic kidney disease Assessment & Plan -Likely prerenal d/t sepsis, bradycardia -Expect to improve as chronotropy, volume and metabolic status stabilize   Supratherapeutic INR Assessment & Plan -Coumadin on hold -INR still > 8 several hours after 5mg Vit K PO give -Give 10mg IV -CT head (-) hemorrhage   Permanent atrial fibrillation Assessment & Plan -On Toprol at home; this is held -On coumadin   Chronic heart failure with preserved ejection fraction Assessment & Plan -Does not appear to be in exacerbation  -Caution with fluids     Physical deconditioning Assessment & Plan -Consult PT/OT/CM, appreciate input   Unspecified hypothyroidism Assessment & Plan -Could be a form of myxedema coma; TSH is 11, TF 1.1 -She is profoundly hypothermic and bradyardic, puffy facies -Give loading dose 200mcg of levothyroxine, then 2 daily doses at 1.2 mcg/kg at about 80mcg -Bair hugger and warmed fluids
Started having muscle spasms and jerking.  Affected his memory and had unsteady gait and fell twice and had to have help walking some.  He had abdominal pain and decreased appetite lost 10 pounds in a week. He was on Keppra from EEG that was done 2 years ago and strikes was seen on the temporal and periorbital but never had no seizure activity.  They increased his Keppra and told him not to get the second COVID vaccine.
p/vax pt found dead on side 5-8min p/being layed down for a morning nap;parent believe child death poss r/t vax;parents states did not fit any of SIDS risk factors x/had vax;
04-07-21 reported fluid in L lung, SOB taking stairs, 1st ER visit 04-12-21 difficulty breathing, fluid drained twice bet. April 12 and May 14,  tooth pulled at one point in between lung procedures, 06-25-21 reported that fluid drained 3 times total since onset in April,  hospitalized July 19 - 26, dr. office to ER by ambulance,  reported August 16 more fluid drained, hospitalized prior to Labor Day (Sept 6) O2 was 52 at a dr. office, hospitalized Sept 15 or 16  for five days,  09-27-21 reported O2 of 70 at doctor office,  first day out of breath since last hospital stay,  pulmonary and cardiac specialists were still conferring, patient was seeking a donation for a portable O2 unit, needing O2 more often throughout the day and night.  Tried to drive to hospital again Oct 4, found unconscious on side of road, in a coma on ventilator until October 11 when family removed ventilator and she passed away.
6-8 hours post vax, the pt developed injection site erythema, induration, pain, itching hives around neck, general malaise, myalgia, fever, disorientation, and mild ataxia. Treated with Benadryl and Tylenol. Recovered within 24 hours.
Erythema, pain at injection sight up to shoulder and down arm, entire arm itching, flushing in face, vomitting, and fever. itching, pain, flushing started within 15 minutes. vomitting started approx 3 hours after injection.
Three days post vaccine (7/25),  I began experiencing a "whooshing" sound in my head that progressed to sever dizziness, nausea, and the feeling that I was going to pass out.  My husband took me to the Hospital Emergency Room where they did an ECG 12-Lead, GFR, Complete Metabolic Panel, CBC with Differential, TROPONIN I, and CT Head W/O Contrast.  All tests came back normal and  I was discharged with a diagnosis of vertigo and given an Rx for meclizine 25 mg and ondansetron.  The next day (7/26) I still suffered from dizziness and vomited once.  The following day I suffered from even worse dizziness that prevented me from getting out of bed  for most of the day and I vomited twice. I had a telemedicine visit and the NP recommended I take Meclazine 50mg every 8 hours and Zofran every 6 hours.  On 7/28, I woke up feeling significantly better and by 7/29. I was pretty much back to normal.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Narrative:  Patient presented to this ED 3/7/2021 - EKG showed Sinus tachycardia with rate of 109 bpm. 1st degree AV block. Normal QT at 396 msec. QTc 533 msec. RAD. RBBB. No ST T wave elevation or depression. Compared to 9/17/19 new RBBB, changed axis and interval changes. Patient was subsequently transferred for further workup. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine
Headache, Myalgia, CoughWheeze, Diarrhea,  NauseaVomiting SOB Narrative:
Redness and warmth at injection site. Possible cellulitis. Referred to health care provider for assessment.
4 days after vaccines given, child has 3 seizures, no fever at that time. Did have a low grade fever 24 hours after vaccine. Full work up done in PICU; all results negative.
Fever, High heart rate Friday and Saturday - typically 60 HR was >90 for 16 hrs Lymph node swelling
Dizziness, fainting, brain fog, headache, not feeling like myself, cognitive delay, visual impairment. I?ve never had issues with my eyes or dizziness.
Pt recvd 1st dose of Hep B vax on 12MAY92; presented to ER & was noted pt was pregnant; On 14MAY92 pt returned to clinic where noted to have no fetal heart tones; @ time of report nurse was unable to confirm state of pregnancy in pt;
Patient hospitalized for Pneumonia due to COVID-19 virus within 6 weeks of receiving covid vaccination.
Headache, Temp max 101.8.  Tylenol, motrin taken. Fever from 8pm 1/27 to 8pm 1/28
Atrial fibrillation; A spontaneous report was received from a consumer concerning a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced atrial fibrillation.  The patient's medical history includes hypertension, cholesterol, and tachycardia. Concomitant product use provided was amiodarone for tachycardia and diltiazem.  On 06-MAR-2021, approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:032M20A) via unknown route in an unspecified arm for prophylaxis of COVID-19 infection. Treatment details were not reported.  On 09-MAR2-021 patient report she had she had an atrial fibrillation, resulting in hospitalization for 6 days.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the events, atrial fibrillation was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M041990, expiry date : 28-JUN-2019) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.; Sender's Comments: US-009507513-1707USA008761: US-009507513-1707USA008760: US-009507513-1707USA008762:
Redness on skin on the left shoulder starting 8 days after vaccine administration. Lasted for 2 days, resolved without medication / treatment.
I started having diarrhea and I pretty much had loose stool daily for 3 weeks. I did not have a regular bowel movement and ended up going to the hospital. I was admitted for diverticulitis in my colon on May 20th, 2021. I was placed on IV antibiotics and pain meds which still did not resolve the issue. I was given magnesium citrate which caused bleeding. I was hospitalized for 7 days. My regular bowel movements did not start until about a month ago. Before the vaccine, I was very regular. I initially did not think that this was an adverse reaction until the diarrhea continued for days. The pain built up and got worse which is when I went to the ER. My bowels are back to normal as far as consistency but I still have pain on my left side and if I am not careful about what I eat, I have issues with my gut.
Vaccine administered 1 day after beyond use date. Pfizer corporation has been contacted regarding stability issues, and contacted clinical coordinator. May revaccinate in the future when given guidance
None- Pt did not report any adverse reactions. Pt was adminitered Pfizer Vaccine before knowing later it was considered expired.
Patient presented to office on 2/24/2020 with fussiness and decreased intake. He was noted to have poor muscle tone and pain with flexion/extension of neck. Patient was sent to ER by private vehicle with parents where he diagnosed with HHV 6 encephalitis.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 13:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Developed what I thought was a rash 11 (3/16/21) days after the injection on my upper left arm at injection site.  By 3/18/21 (13 days after injection) I had a large, red, tender and warm to the touch circle in my upper left arm.  I went to UTC, who determined I had an infection.  They prescribed antibiotics (Keflex) and it seems to have subsided.  I reported it to my doctor and also called the health department, who said someone would call me about it but I never heard from anyone.
Given an expired IPOL to a patient/ No AE; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 23 years old female patient who received an expired dose of vaccine IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication was not reported.  On 14-May-2020, the patient received a 0.5 mL fourth dose of suspect IPV (VERO) (lot P1A251M and expiry date 02-May-2020) via unknown route in the right deltoid for prophylactic vaccination.   It was an actual medication error case due to expired vaccine used.   At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Shortness of breath, cough, stabbing chest pain, tingling in fingers in toes started on june 3 about 28 hours after shot symptoms have progressively gotten worse high blood pressure and headaches also