chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Progress NOTE on 1/17/22 76-year-old female with past medical history of paroxysmal atrial fibrillation on Eliquis, diabetes type 2, hypertension, hyperlipidemia, lower extremity swelling who presented to the ED on 1/16 complaining of shortness of breath that began approximately week ago.  She states that she did receive her COVID-19 booster shot on Tuesday 1/11 and has been feeling slightly ill since that time.  She also had significant weakness, malaise, shortness of breath, nausea and 4 episodes of vomiting.She was recently seen by NP cardiologist on 1/12. and was recommended to continue metoprolol.  She previously was suppose to be taking diltiazem but was not sure if she was actually taking this.  She also was started on furosemide 20 mg  On arrival EMS found her to be in atrial fibrillation and found to have an oxygen saturation of 74%.  She also had a right lower extremity weakness which is due to a fall couple weeks ago she was given 4 mg of Zofran.  In the ER she was found to be tachycardic with heart rate up to 120s after was started on Cardizem drip.  She is found to be hypoxic 86% on room air, blood pressure 124/61.   proBNP 1833, troponin negative, procalcitonin 23.37, blood cultures negative to date preliminary, COVID-negative, RSV influenza negative, WBCs 9.4.  Chest x-ray read showed no identifiable acute cardiopulmonary disease.  CTA of the chest shows patchy groundglass opacity in the lung base left greater than the right.  Consistent with infections/aspiration type changes.  She was started on azithromycin, Rocephin.  Electrophysiology did evaluate patient and did recommend increasing her metoprolol from 25 mg twice daily to 50 mg twice daily as well as continuing her Eliquis.  #A-fib w/ RVR - recently changed from diltiazem & metoprolol to metoprolol alone and lasix. On eliquis.  Electrophysiology was consulted and recommends increasing her metoprolol to 50 mg twice daily.  Monitor closely  #Acute hypoxic respiratory failure w/ initial oxygen 82% on RA likely 2/2 to a-fib w/ RVR and CAP.  Rocephin, doxycycline. Monitor  #Significant 2nd hand smoke exposure > 50 yrs - recommend outpatient f/u with PCP for PFT's and repeat imaging once feeling better.  #CAP w/ elevated procalcitonin. Tx as above #N/V/cough/ possibly 2/2 to vaccine reaction? - COVID negative. Has been ill since vaccine.  F/u on Cortisol level. Will report     #Severe Hypomagnesium, mild hypokalemia - replace and monitor closely.  #DM2 - f/u w/ HgA1c. Hold Metformin and Januvia, glipizide  #LE edema - improved after lasix. Lasix has been held  #HTN - Lisinopril held  #HLD - Atorvastatin # Mild to mod Tricuspid regurgitation,  Mitral regurgitation on ECHO 1/10  # Obstructive sleep apnea (unable to tolerate cpap)   #Elevated Pro-BNP, likely 2/2 to A-fib.    1/20/22 Review of systems: No fevers or chills No nausea vomiting or diarrhea, no abdominal pain No chest pain or shortness of breath HEENT is negative Skin is negative 1/21/22 Discharge home
9 hours after I received the shot, I experienced a fever, severe chills, headache and body and muscle aches. I did not experience pain in my arm.  These symptoms continued throughout the subsequent 54 hours.  Fever was 102 at the highest and chills were on and off.  I took advil every four hours during that entire period, which helped, but didn't completely mask these symptoms. This came on suddenly at first.
Within 48 hours post vax, the pt was found not breathing and had no heart rate. Following the vaccination she had been very tired and missed some feedings. When she was found not breathing, she was rushed to the hospital and within an hour of being found they were able to get a heart rate with resuscitation  efforts. She remained intubated in the hospital but was brain dead and died on 10/21/00. Autopsy states cause of death as pneumonia.
This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest), FEELING ABNORMAL (thought the patient was dying), INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. Concomitant products included HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) for Back pain. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest) and FEELING ABNORMAL (thought the patient was dying). In April 2021, the patient experienced INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from April 2021 to 2021 for Breathing difficult, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLOVENT HFA) from 2021 to 2021 for Adverse event, at an unspecified dose and frequency. In 2021, INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath) had resolved. At the time of the report, PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest) and FEELING ABNORMAL (thought the patient was dying) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: positive (Positive) Positive. On 06-Apr-2021, approximately 12 hours after the administration of the second shot, the patient felt like passing out and heart rolling down in chest. On 07-Apr-2021, the patient felt a little better but a little off. The patient was scared to death due to the booster dose. A couple of weeks after the second shot, the patient did not feel the need to use an inhaler at all. The reaction subsided over weeks after and now the patient does need an inhaler at all. The patient's D dimer was always positive but the patient did not have blood clots so the patient thought that it was caused by inflammation.The patient was scared to get Johnson and Johnson vaccine. The patient did not have factor 5.The patient was never diagnosed with myocarditis or pericarditis nor had a history of it. The patient did not have a history of COVID-19 infection. Flovent HFA was used for a couple of weeks thereafter. This case was linked to MOD-2022-439850, MOD-2022-439943, MOD-2022-439921 (Patient Link).
Nov30,2021, I got my booster on December 28/2021 in the evening around 5:00pm I started with tiredness, I left like a very bad flu. I have fever, body ache, fatigue, sore throat. It lasted a few days. A week after I called my doctor I told him what happened he said had sinus infection. He said I had omicron. He gave me antibiotics for 10 days.
Vaccine administered 4/28/23  in office with no adverse events. When auditing a few weeks later 7/15/23, realized wrong vaccine was given to patient. Contacted patient's mother and informed of vaccine error. Staff meeting will be held on Monday to educate staff about vaccine administration procedure.
Fever for three days, 99-100. Large rash on upper left arm. Headache, rapid pulse for one day.
I had the normal soreness at place of shot for about 2 days.  But since then, I have had pains in my arm.  They are very similar to pains associated with rotator cuff injury.  I recently had rotator cuff surgery on left arm so I know the symptoms.  It actually hurts more than my left arm felt prior to surgery.   I also have had constipation. I do not know if both of these symptoms are coincidental or not but wanted to let you know.
Hives all over body.  Swelling of toes prescribed predinsone, was given a steroid shot, and take benadryl every 4 hours.  Has not resolved yet.
2 inch diameter red swollen area at site of administration.  Give Benedryl. After hours call f/u given for appt 5/24
Diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6205), via an unspecified route of administration, on 04Mar2021 14:00 (at age of 72-year-old) as single, in Arm Left for Covid-19 immunization. The patient's medical history included poly myalgia rheumatica. The patient's past drug event included erythromycin with reaction included drug allergy and he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL9269), via an unspecified route of administration, on 09Feb2021 01:30 PM (at age of 72-year-old), as single in Arm Left for, Covid-19 immunization. The patient's concomitant medications included prednisone, amitriptyline, lorazepam and ezetimibe. The patient did not have covid prior to vaccination and was not tested positive post vaccination. The patient did not receive other vaccine in four weeks. On 05Mar2021 12:00, the patient experienced diarrhea. The patient received treatment with Pepto Bismol and Immodium for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
My menstrual cycles have been shorter, lighter and not 'normal' even for a 46 yr old perimenopausal woman. A definite change. From 26-28 days (past 12 were exactly 28) to mar-apr 21 days; April to may 21 days; may to June 24 days.  Each month also only heavy flow one day, as opposed to a usual 3. And 2-3 light days then done  Also increased incidence of hormonal migraines.
Client received his COVID Pfizer Pediatric dose #1 lot # FF5127 exp. 01.24.22 on his left arm on 12.12.21 at 1644. At 1653, client?s mother reported to EMT that client started having rash on his face and neck within five minutes after receiving the COVID Pfizer vaccination, and he transported client to the anti-gravity chair in a semi-fowler position. At 1653, EMT took client?s HR 68 and O2 Sat. 90%. At 1653, client?s mother told PHN to give child Benadryl ASAP because she knew that client was experiencing signs and symptoms of allergy since he had the same rash on his face and neck when he was allergic to bee sting, chlorine, wasp, and stepping on a metal. PHN assessed client. PHN prepared the 0.6 ml dose IM Benadryl lot # 031027 exp. 03/2023 and another PHN verified the 0.6 ml dose IM Benadryl for a 60 lbs. child per his father. At 1655, PHN vaccinated the client on his right arm with IM Benadryl 0.6 ml. Project Clinical Lead helped with EMT station while EMT and PHNs assisted client. At 1701, EMT took client?s vitals: BP 98/65, HR 92, O2 Sat. 99%, and client?s mother told PHN that the Benadryl helped with his rash on his face and neck to improve. Client has no progression on his rash and no anaphylactic signs and symptoms. At 1706, EMT took client?s vitals: BP 102/64, HR 94, O2 Sat. 99%, and client?s rash on his face and neck were improving. Client denied any signs and symptoms of anaphylactic. Client?s mother told PHN that her son is not on any medications or has any food allergy. At 1712, EMT took client?s vitals: BP 98/64, R 24HR 69, O2 Sat. 99%, and client reported he?s ?feeling good.? Client was alert and oriented x 4. At 1720, PHN listened to his lungs with her stethoscope, and his lungs were clear to auscultation. At 1724, EMT took client?s vitals: BP 98/62, HR 66, O2 Sat. 99%, and client?s rash improving on his face and neck with no other symptoms observed. At 1724, PHN educated client?s mother on adverse reactions and when to seek EMS. PHN referred client?s mother to take client to follow-up in a week with client?s pediatrician before his second COVID dose. At 1726, client left HCF site with a steady gait with his parents and sister.
About 11am on date of vaccine arm soreness extending across back to other shoulder, minimal swelling at site, chills and hot flashes lasting 24 hrs. Soreness and swelling still present today but improved.
Patient is a 52 y.o. male with 7-day history of severe shortness of breath that is worse with exertion and improved at rest.  This is associated with cough.  Patient did note some scant blood-tinged sputum that has now resolved.  He notes generalized weakness.  He also has a little pain with cough.  He was found to have borderline hypoxia emergency room and was admitted for steroid and antiviral therapy.  He is vaccinated and has received antibiotic infusion.
Autoimmune flare up. Tingling sensation in skin, joint pain in fingers, pain in back of right knee, pain in tongue, numbness in face, especially around ears and nose. Shortness of breath, fatigue, light headedness. Symptoms began about two months after vaccination and reduced but ongoing after 6 months. I have had similar symptoms in the past, although this was the most severe flare up.
Extreme swelling of the arm from the elbow to the shoulder. Skin was very red and hot. Swelling and redness extending below the elbow. Treatment: cefelexin 10 days and difenhydramine. Took 10 days to heal.
Allergy to thimersol rash, swelling red, hot arm 2 day after shot.
Information has been received from a physical therapist concerning a 1 year old female who on 19-JAN-2007 was vaccinated with a dose of Varivax. On 29-JAN-2007 the patient experienced a chickenpox outbreak. The outcome was not reported. Additional information has been requested.
Swollen underarm lymph node (ongoing) Cold sweats (lasted approx. 32 hours) Chills (lasted approx. 32 hours) Body aches (lasted approx. 32 hours) Headache (lasted approx. 32 hours) Fatigue (lasted approx. 32 hours) Sore throat/dry mouth (lasted approx. 32 hours) Sinus congestion (lasted approx. 32 hours)
pt recvd vax & felt somewhat lethargic for rest of day;no erythema; edema lt arm, but c/o dull aches x's 7wk, which has inc in intensity over 2nd wk;ROM good, but painful;taken med for pain
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD. No adverse effect reported. The temperature excursion details included exposure to temperature of 6 Fahrenheit for 8 hours. No previous temperature excursion reported. No additional doses have been administered. This is one of several reports received form the same source. Additional information has been requested.
Bad immune system; Sick; Headache; Diarrhea; throwing up; This is a spontaneous report from a contactable consumer (patient) from a Pfizer. A 68-year-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FC3180, expiration date: Oct2021) (age at the time of vaccination was 68 years) via an unspecified route of administration on 06Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included COVID 19. Concomitant medication was not reported. The patient had an immune (Clarification unknown) and a lot of health issue, her first dose of the vaccine was given on 06Aug2021. The patient stated that I had my first shot and I had COVID (later clarified as medical history) so when I got my shot I had the same symptoms headache, throwing up, everything that was in about a week. I have a very bad immune system and lot of things going on but I am 68, I will be 69 in October, no big deal but I take care of myself as best as I can. Consumer further stated, so my first Injection I got sick immediately, headache, throwing up, diarrhea and I felt like (incomplete sentence) and I had a headache every day, it's like a week and half, every day. The outcome of the events was unknown.  Follow-up attempts are completed. No further information was expected.
chills, shivers, nausea, muscle aches over the entire body but especially around the area of the injection, soreness at the sire of injection,.
1cm nodule in left neck, 1 adjacent sub cm in size and palpable lump just above the clavicle which was a probable reactive lymph node; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via agency (Reference number- 00332508) and transmitted to Sanofi on 26-Oct-2020.  This case involves a male patient (unknown demography) who developed 1cm nodule in left neck, 1 adjacent sub cm in size and palpable lump just above the clavicle which was a probable reactive lymph node (lymphadenopathy),while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not get any concomitant vaccines.  On an unknown date (reported as on 19th), the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2034, expiration date: 30-Jun-2021) via intramuscular route in left deltoid for prophylactic vaccination.  On an unknown date (also reported as through the night of the 20th and the 21st), the patient developed a non-serious palpable lump just above the clavicle and 1cm nodule in his left neck and 1 adjacent sub cm in size (lymphadenopathy) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (unknown latency).  Relevant laboratory test results included: Ultrasound scan performed after 48 hours of vaccination showed probable reactive lymph node.  It was not reported if the patient received any corrective treatment or not.  The reporter stated that they were not sure if it is a reaction but they wanted to check to see if this was a possible reaction or just incidental. Reporter also stated that the radiologist who did the ultrasound thought there was no correlation.  At the time of report, outcome of lymphadenopathy was unknown.
Post vax, had some pain in left arm all week. Last night, 3/6/00, left upper arm red, swollen, fluid filled papule, warm to touch.
10 hrs after vaccine; achy and unable to sleep. Next morning (20 hrs after vaccine)- broke out in rash, itchy bumps 6+ days later- still have rash. Rash is not consistent in location. Benadryl helps with itch.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 36-year-old female. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 18-AUG-2016, the patient was vaccinated an expired dose of oral ROTATEQ (dose unknown, lot # K022990, expiration date 26-JUN-2016 orally. No known adverse effect reported. Additional information has been requested.
ACUTE NON ST ELEVATION MI 1/17/2023 CHF EXACERBATION, UNSPECIFIED ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 1/7/2023 CHF EXACERBATION, UNSPECIFIED ACUTE RESPIRATORY FAILURE 1/17/2023 CHF EXACERBATION, UNSPECIFIED CARDIOGENIC SHOCK 1/31/2023 CHF EXACERBATION, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/17/2023 HX OF NON ST ELEVATION MI  ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 1/7/2023 HX OF NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE 1/17/2023 HX OF NON ST ELEVATION MI CARDIOGENIC SHOCK 1/31/2023 HX OF NON ST ELEVATION MI
Client states wheezing, SOB, congestion at x's.  Since both shots. States Symptoms since late January (before vaccines). Reports 2 bauts of bronchitis since Covid series. Treated with Steroids, + antibiotics. CXR neg. No CTScan done. Labs neg. States MD felt SX could be related to vaccine. Also treated with albuterol Inhaler.
The next day post vax, the pt developed a rash at the injection site that extended from the deltoid to the elbow. The pt recovered within 2-3 days.
No adverse event, gave moderna in error to 13 year old when it is indicated for 18 and older
Fever of 102 degrees, dizziness, vomiting, diarrhea, muscle aches, joint pain, fatigue
Fever (100.5) approx. 24 hours after receiving shot. Lasted 3-6 hours, followed by 24-48 hours of fatigue and slight shortness of breath.
Hives all over her body; She couldn't swallow; Hives in her arm at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body), DYSPHAGIA (She couldn't swallow) and VACCINATION SITE URTICARIA (Hives in her arm at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, 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 experienced URTICARIA (Hives all over her body), DYSPHAGIA (She couldn't swallow) and VACCINATION SITE URTICARIA (Hives in her arm at the injection site). At the time of the report, URTICARIA (Hives all over her body) and VACCINATION SITE URTICARIA (Hives in her arm at the injection site) had not resolved and DYSPHAGIA (She couldn't swallow) was resolving.            No relevant concomitant medications were reported.   Treatment information included steroids, medicine to drink for dysphagia.  Patient went to the family doctor and the physician prescribed steroids for six days. At that time, patient couldn't swallow, so patient was sent to the emergency room on 17 Mar 2021, they gave her something to drink which allowed her to swallow again. Then the patient went to a gastrologist, and who put something down her throat and took a biopsy. The biopsy result was unknown at the tome of this report.  Action taken with mRNA-1273 in response to the events was not applicable.