chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On March 20 Patient started to have confusion.  By March 23 he developed high fever 102.8.  He went to his ID and a murmur was noted.  He was worked up with a ECHO and had developed a tear in his Mitral Valve to the point of appendages barely holding it.  He developed Uncontrolled A-fib and ultimately had Mitral Valve Replacement, extended hospital stay due to stroke.
I was being vaccinated with the Pfizer booster; I was being vaccinated with the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was being vaccinated with the Pfizer booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I got positive to covid on Monday morning. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Consumer stated that the reason I am calling because I got positive to covid on Monday morning. And in the evening went to ER and they offered me the medication, I was being vaccinated with the Pfizer booster (further clarifications unknown hence, suspect captured as unspecified booster) one so I did accept to take the treatment called it Paxlovid. I was aware of the side effects, and I had a hoarseness in my voice, but I thought it was I was coughing so much. You can listen to my voice, it was hoarse. I do not have any more fever. I feel ok except of this cough I don't have any more productions. I was ok, my stool got a little soft yesterday, I did not go yesterday but I went today but they are very pale. And that was what I am here because of that. I am calling to ask you advice to see what should I do.  Follow-up attempts are completed. No further information is expected.
pt recvd dtp, hib, hep B 23jun94; no report of any rxn; pt became ill 10oct94 w/ some type of liver related illness; pt died 31oct94; autopsy not avail at this time;
Patient is 44-year-old female with complaints of a reaction following the tetanus vaccination.  She reports initially she "did not feel myself".  She had body aches and just did not feel normal.  The following day she had pain in the left arm.  Very difficult to lift her arm up and move it.  She complains of having a headache 48 hours later.  She had a temperature to 101 degrees, body aches, with wrist, ankles, and knees hurtings.  It felt like the "flu".  Her arm was red and hot where the shot was given.  No vomiting or diarrhea.  No one else was sick.  She reports decreased appetite while she was ill.  Went to Emergency room at approximately 50 hours after injection.  She reports in the Emergency room she was given 80 pills of 250 mg of keflex.  She was told to return to emergency room for follow-up the next day.  She returned for recheck and the arm redness had spread a little.  She reports feeling much better.  She took some motrin for the fever and body aches.  She is now 5 days status post injection and feels "good".  No body aches or fevers or chills.  No change in urine color.  Still taking the antibiotics.
Starting on 2/19, I noticed that there was blurred vision in my left eye, It got worse over the next few days. I went to an optometrists on 2/22. They couldn't find anything wrong but there was significant vision loss that was constant throughout the day. It continued so I went back where I had more tests done but still, nothing was wrong. At the time of the appointment there was nothing physically wrong with the eye or never that the doctors could see.
NURSE ADMINISTERED PFZIER VACCINE # 3 TO 17 YEAR OLD PATIENT. CURRENTLY BOOSTER IS APPROVED UNDER EUA FOR 18 YEARS AND OLDER. PATIENT DID NOT QUALIFY.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: pt brought over by pharmacist to clinic- vitals 88/52 HR 80 glucose and fluids given- pt placed in supine position- improved with interventions-
15 minutes after the injection I experienced Intense Headache,  Fever, hypertensive event  increased from 110/70 to 146/86, shortness of breath, chest tightness, whole body fatigue. The following Wednesday the shortness of breath increased enough, my primary physician?s office directed me to go to the ER.
Expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A pharmacy administered doses of the Moderna vaccine 1 day after the published expiration date. Approximately 30 doses were administered from 2 vials as a combination of primary and booster doses. The pharmacist did not describe any symptoms after these individuals received the vaccine, however he has not followed up with these individuals.  On 10-FEB-2022 MOD-2022-479841 became invalid as it was confirmed that there is no specific patient who received the Moderna COVID-19 vaccine. Therefore, this case will be logically deleted from safety data base
Had one dose in each shoulder, 1st in Feb, 2nd in Mar. Had mild fever, tiredness, headache, joint pain. Arm was sore for 5 days after 2nd shot.  Afterward developed persistent inflammation and discomfort in both shoulder joints.  Arm painful to raise above shoulder height. Has partially resolved but discomfort remains.
This spontaneous report as received from a female patient of unknown age regarding herself. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported). On an unspecified date in December 2013 the patient experienced injection site pain and swelling that continued one week after receiving ZOSTAVAX. No PQC was reported. It was also reported that therapy of ZOSTAVAX was not discontinued. At the time of reporting, the outcome of injection site pain and swelling was unknown. The patient sought medical attention by calling her pharmacy. Additional information is not available.
Pt came back w/ complaints of pain/fever/chills. She came back & had a 3x5 inch bruise on (R) arm around lateral bicep area that was black & blue (pneumonia side), and a smaller bruise 2x3 inch on left side (FLUZONE HD).
c/o pain/swelling right arm are where he had Pneumovax injection on 3/15/11
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 22Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jun2021, patient experienced diarrhea and complaining about diarrhea for the last 6 days (for a week now). Patient wanted to know the treatment and how long will this last, what was going to happen and what was going on with his body. Patient was advised to contact his doctor/healthcare provider. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
About 5 minutes post vaccine patient began complaining of feeling shaky and a little light headed.  Breathing, color, and mentation appeared fine.  Patient given water and crackers (had not had breakfast) and told to lie down with feet up if he became more lightheaded.  Patient was observed for 20 minutes, during which time he developed chills and became sleepy.    He also had what appeared to be impetigo on nose near left nostril, which the father was advised to seek medical care since it would likely require an oral antibiotic.    Patient appeared stable and was allowed to leave and again father was advised to seek additional care if symptoms worsened and also for evaluation for likely impetigo.     Spoke to father at 12:16 pm, they had gone home since patient was tired and wanted to lie down.   AT home he developed additional chills, body aches and was given tylenol.   The father was calling urgent care to get an appt for son to be evaluated.
10 days after vaccine I developed a constant cough which disrupted my daily life for at least six months.  I was unable to talk for any length of time without coughing.  was unable to run (which is something I do in all year round). There were times where I was coughing so bad I couldn't breathe and other times where the violent coughing caused me to pull muscles in my back.  Almost one year later, if I stop taking Zyrtec the cough will return.
5mins after (COVID) vax, pt felt tightness center chest at sternum and tightness in upper back 5/10 tightness and discomoft (Buspor/wellbutrin) 4 lead, NSR PMH:fibrocystic breast tissue, allergic to latex. Pt reported improvement with rest and left. 14:29 110/58 p95 r16 99% 14:33 120/76 p91 98%
One day post 2nd Moderna Vaccine administration, patient reports her right arm (same as injection) began hurting and was reddened at vaccine site. Later in the day she experienced pain in armpit and up the right side of neck causing her to have a head ache.
reaction at injection site, redness and swelling around injection site, fever,  pain (fever is now gone, patient still has very sore arm)
He received two previous doses.   He ask for his second dose like the card indicated.  Once one of the technicians enter to database noticed it was the third one.  This patient is not an immunocompromise patient .
Diarrhea; Vomiting; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included she gets sick from bad food. The patient's concomitant medications were not reported. The patient had taken the Pfizer vaccine 2 days ago, her first dose, and she was vomiting. She was not sure if it was related to the vaccine or if it was from something she ate last night. She also had diarrhea, and she wanted to take ondansetron (ZOFRAN) that she had been prescribed to her from the past, from other problems. She gets sick from bad food. She has had it in the past, but she cannot stop vomiting. The pharmacist wanted to know if there were any known interactions between ZOFRAN and the Pfizer vaccine, and also if it was a known side effect, or if people were calling about vomiting. The pharmacist asked, you do not have anything related to the Pfizer vaccine and then any interactions on your part? You do not have any information about that? The clinical outcome of vomiting and diarrhea was unknown.  Information on the lot/batch number has been requested.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received PfizerVaccine on 2/13/21 and 3/03/21. Presented to ED  c/o SOB shortness and cough x/1 wk. Admitted for acute hypoxic respiratory failure due to COVID-19 and requiring high-flow O2. Course c/b rectal bleeding and hypovolemic shock; tx'd w/Phenylphrine. ABG showed severe hypoxia requiring intubation but patient requested DNR status. Tx'd with IV vancomycin, Rocephin and doxycycline. His oxygenation continued to decline, transitioned to comfort care. Pt expired 3/03/22.
Pain in side below my armpit to the left outer edge of my breast stretching to beginning edge of my back.  Swelling with fluid swishing around.
Information has been received from a medical assistant concerning a 63 year old Caucasian male patient with sulfa allergy, chronic obstructive pulmonary disease, hyperglycemia, and hypercholesterolemia who on 11/30/01 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent IM in the left deltoid *(lot number 641350/1351L). On 12/31/01, the patient developed a local site reaction. The patient's arm was red, swollen, hot to the touch and painful. The patient used ice and took diphenhydramine and ibuprofen. Unspecified medical attention was sought. On 12/5/01, the patient recovered. The reporter requested a lot check on lot 641530/1351L. The records of testing prior to release of this lot had been checked and found to be satisfactory. The lot complied with the standards  and was released. The patient's wife also developed injection site swelling, warmth, and ecchymosis post vaccination with pneumococcal vaccine 23 polyvalent (WAES0201USA00493). No additional information is expected.
BLOOD PRESSURE WAS REALLY HIGH AND STAYED LIKE THAT FOR THREE WEEKS. BECAUSE OF THE HIGH BLOOD PRESSURE I HAD A LEAK IN MY VALVE. EVER SINCE THE VACCINATION I FEEL LIKE I HAVE BRAIN FOG.
requested medical records but never did receive them; pt had a positive COVID test on 7/18/21; per death certificate, pt died in the hospital with the causes of death being Acute Hypoxic Respiratory Failure, COVID pneumonia, SARS COV2
On 9/4/21 started feeling very sick- fevered. From 9/5  through today 9/10/21 I have been feeling very fatigued. Cough, shortness of breath, and low grade fever.
SWELLING, HEAT, RASH OF BOTH LOWER LEGS, ANKELS AND FEET STILL FEVER OVER 101. AFTER 24 HOURS, ON SECOND DAY AFTER HIVES OVER 70% OF BODY. REQUIRED VISIT TO PHYSICIAN PRESCRIBED PREDIZONE 60 MG PER DAY X 4 DAYS.
Pt administered Flu shot 9/13/10. On 9/17/10 pt developed neuralgia RLE consistent with herpes zoster. Took valacyclovir x 10 days. Had a small rash develop in thigh at site of pain a few days later - pain and rash have resolved.
2 days p/vax c/o numbness in fingers bilat;a day later numbness in toes, it became progressively harder for pt to ambulate, dress, herself or work d/t weakness & stiff in legs;saw MD;dx as GBS;
Fever to 103.6 at home 39.7 ion Er (41.7) after receiving x 1 day. emesis. No rash no resp. distress initially. In hospital, developed slight wheeze (resolved and albuterol nebs and po prednisone). Continued febrile until started ceftiocoreal abd + DXR fils neg for ? and c/w viral illness.
Information has been received from a registered nurse for GARDASIL a pregnancy Registry product, concerning a 17 year old female patient who on 16-MAY-2011, was vaccinated with the first dose of GARDASIL (route and lot number not reported) while pregnant. The patient's last menstrual period was on 11-APR-2011 and estimated delivery date would be 16-JAN-2012. No symptoms reported. The patient sought medical
Sore Right Arm; 30 Weeks Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Right Arm) and MATERNAL EXPOSURE DURING PREGNANCY (30 Weeks Pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory tract infection (In OCT-2020, tested negative for COVID-19). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), BUDESONIDE (PULMICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Jun-2020 and the estimated date of delivery was 24-Mar-2021. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Right Arm) and MATERNAL EXPOSURE DURING PREGNANCY (30 Weeks Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 12-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (30 Weeks Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Right Arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Patient had previous pregnancy one and delivered Live, full-term birth baby.
Client fell onto the floor c/o dizziness. Alert, awake, oriented x 3. Skin pale, called 911. N.S. P-68, R-18, B/P 110/58
Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The BUD date was reported as 26-Mar-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided.  The vaccine was stored in standard freezer on 30-Nov-2021.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
Myalgia, Arthralgia, Fever, BODY PAIN, ARMPIT PAIN, RIGHT GROIN ACHES Narrative:
hard of hearing; This is a spontaneous report received from a non-contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Tylenol for bad shoulder. Patient reported that usually took Tylenol daily for bad shoulder. Had 2nd dose of covid vaccine yesterday and would like to know if he can take Tylenol again. Clarified had not taken Tylenol since vaccine. He mentioned being hard of hearing and to speaking. Not clarified if he was hard of hearing before or after vaccine. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12C for an estimated total time out of range of 14 hours. On 01-JUN-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
second vaccination triggered shingles outbreak; it triggered shingles outbreak; i am in pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix which triggered outbreak of Shingles. At the time of report, the patient was in pain and not impressed. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The reporter consented for follow up.