chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via Pfizer concerned a 28 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A, expiry: unknown) dose was not reported, 01 total administered on 09-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 27 years old. The patient additionally received non-company suspect vaccine elasomeran (Moderna) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 012F, expiry: unknown) dose was not reported, administered on 24-OCT-2021 for covid-19 prophylaxis, which was revaccination with different covid-19 vaccine (Dose number in series 2). Concomitant medications included ethinylestradiol/norgestrel (Low-Ogestrel) for birth control, sun genomics as concomitant probiotics product.  On 24-AUG-2022, the patient experienced confirmed covid-19 infection (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive.  The patient was treated with Paxlovid for COVID-19 (coronavirus disease) from 24-AUG-2022 to 29-AUG-2022.  On 30-AUG-2022, the patient tested negative for COVID-19 virus test. On 08-SEP-2022, the patient again tested positive for COVID-19 virus test (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of revaccination with different covid-19 vaccine and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000252080.; Sender's Comments: V0:20220933468-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
pt recv vax 17SEP96 & 20SEP96 pt devel a red measles looking rash on legs, the bottom on feet & face;reporter felt rash was r/t varicella vax;
I had a rash in the area of my rectum that was bleeding red blood. It lasted maybe 2-3 days. I did not have the same thing happen when I had the second shot. I was not having trouble with bowels or anything. My arm hurt really bad as well. I had a fever for about 3 hours and then it was done. I had surgery on the 16th and could not get control of the swelling no matter what I tried. I told the doctor's office what was going on. Since I am allergic to NSAIDs and that being the best for swelling, I wasn't able to take anything. I was in a lot of pain and the swelling would not go away. I went back to see the doctor on 4/26, that is when they took the cast off. I started going to therapy right away. I was so frustrated with the swelling I went to the doctor and got a new cast. Nothing changed. After all that I started full therapy. The therapy is helping.
PATIENT WOKE UP COUGHING, WITH AN EXTREMELY HOARSE SORE THROAT, ACCOMPANIED BY RAPID BREATHING THAT WAS LABORED, HE COMPLAINED THAT HIS THROAT HURT.
Patient experienced cellulitis following ADACEL shot. Patient was treated with BACTRIM DS twice daily for 7 days.
fever, chills, sweats, myalgia, arthralgia, nausea, diarrhea w/in 24hr of vax;laryngitis w/dysphonia,nonproductive cough began 6/15/99;ER visit 6/16;allergy clinic 6/18/99 found to have lt maxillary sinusitis w/laryngitis;tx amoxil;
Dyspnea, cough Dexamethasone, Remdesivir, Tocilzumab
Initial report received on 20 January 2009 from a consumer, who is the patient's parent. A 4.5 month old male patient, with a history of environmental and food allergies, received a second right leg injection of DAPTACEL (lot number C2799AA) and a right leg injection of PREVNAR (other manufacturer, lot number not reported) on 18 April 2008. The patient had no concomitant medications and no illness at the time of vaccination. He had received no other vaccinations in the previous four weeks and had no adverse event following prior vaccination. After an unspecified amount of time on the day of vaccination (18 April 2008), the patient's right leg became extremely swollen and red, lasting for one week. Also, two to three days after vaccination, the patient had two episodes of "full body tremors" on that one day. The patient did not lose consciousness. He had no subsequent episodes of tremors since that day. No other information was provided.
This spontaneous report as received from a physician refers to approximately 65 year old male patient. The patient's pertinent medical history, drug reactions/allergies were none and had no other concomitant medications. On 26-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 milliliter (ml), subcutaneous in deltoid area. On 14-DEC-2013, the patient presented with supraorbital shingles (medically significant). The patient sought medical attention (office visit) and was treated with VALTREX. No laboratory diagnostic studies performed. The patient was seen 2 days later for follow up. Physician stated the event shingles was mild and the patient seemed to be stable, his eye seemed to be fine, and no other follow up was needed with the patient. The patient was recovering from the event. No product quality complaint (PQC) involved. Reporter's causality was not provided. The event was considered as medically significant since the event required intervention to prevent serious criteria. Additional information has been requested.
2nd dose-Very large and inflamed red rash over very hard lump at injection site. Very tender, extremely warm and swollen. Chills, body aches 24 hrs after shot 1st dose-no symptoms, delayed site reaction 7 days later. Red, swollen, warm, lump. Smaller than after 2nd dose and resolved faster.
PT WAS DESCRIBED TO HAVE A VASOVAGAL REACTION; EYES ROLLING BACK , FAINT REACTION WITH MOUTH YAWNING INVOLUNTARY; PT BECAME RESPONSIVE WHEN AMBULANCE CAME AND TOOK HIM TO THE ED  BP 80/50 PULSE 49.
Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hospital at 1am. Took 3 bags of fluids, Ativan, Tylenol and Toradol to get the heart to the 110's over the 3 hours there. It is now 12:30 on the following day (3/7) and the fever, shakes, and elevated heart is starting up again but not to the extreme of last night
Began 9 pm night of shots -> chills, soreness at site of arm; Did not record temperature, weak, achy, flu-like symptoms, fatigue, nauseous-> lasted 2 days off work.
This medically confirmed report received via a sales representative (initial receipt 26-MAR-2014) concerns a female patient. Her current illness was reported as prophylaxis. On an unspecified date, the patient received a high dose flu vaccine (manufacturer and batch number not reported), ZOSTAVAX  (batch number J000429, expiry date 10-APR-2014) and PNEUMOVAX (batch number J007059, expiry date: 14-JUL-2014) on the same day. On an unspecified date following the administration of the vaccines, the patient developed a cough, felt fatigued and felt sick. Her lungs hurt from the coughing. The patient developed pain in her arm. The patient sought medical attention and went for a chest x-ray, in which the results were negative. Outcome was not reported. Reporter's comments: The health authority assessed the case as non-serious. Causality assessment was not provided. The authority reported term was "chest x-ray normal".
Terrible chest pain, shortness of breath, sharp pain in cheek with chewing, loss of voice. Guessing pericarditis or myocarditis after seeing reports on the news
Patient was given Menactra and HPV vaccine in rt arm. Pt. complained of pain and then numbness in Rt arm, wrist and hand, able to move fingers. Arm, no color change. Pt. then had 5-10 min of intermittent shaking, pt was awake, sleepy after shaking resolved. pt was given water. Pt recovered fully in office and sent home. Pt C/O pain in rt deltoid area when raised arm overhead rest of exam was NL. Injection site was NL. Pt had not eaten since almost 5 hrs prior.  F/U phone call several hrs later - pt was fine (pt was anxious per MA but he received the injection).
Large hemorrhagic stroke with severe headache & throwing up. Not sure when it actually happened but found her on bathroom floor when I woke up. Transported to local hospital & transported to Neuro icu at major hospital. Now in nursing home with rehab. Unable to assist yet with much therapy. Impaired vision, can't feed herself or sit unattended.  Very groggy & sleepy. Never lost consciousness.
Patient recovered MENACTRA and ADACEL. She then walked out into the waiting room and fainted. She stated her head hurt and she was on the floor. Mom witnessed her falling backwards and believes she hit her head on the office chair. She thinks she was unconscious for about 5-8 secs. when she opened her eyes then were both turned to the right for 3 secs. and she thinks her right arm had tonic arthritis. She had no further issues/symptoms
Patient was given a the Covid vaccine 2 days past the recommended "Use By" Date. The box said to use by 01-24-23 and the vaccine was administered on 01-26-23.
Pt arrived to be evaluated on 10/13/2021 for sore throat (started 10/9/2021) and SOB (started 10/7/2021) with exertion. Pt reported that she was admitted to hospital on 10/7/2021 for evaluation of SOB. She had a history of PE that caused her to flat line in the past. She was evaluated with various tests like a stress test and ekg and told the provider today that "everything was normal". However when reviewing pt's meds today, she couldn't explain the new rx for a beta blocker (Metoprolol) that was added to her med regimen at discharge on 10/10. Pt reports she didn't think she needed it so she hasn't been taking it. I then asked her more about it and she then disclosed that she thought she was diagnosed with an heart arrhythmia that she was diagnosed with prior to this hospitalization. I asked if she disclosed that she had her 3rd covid vaccine on 10/3, just days before being admitted and she reported that she had not. Not sure if the two incidences are at all related but due to the proximity of the two, reporting to vaers.  Pt is still having the sob symptom, so recommended further evaluation at higher level of care.
This spontaneous report was received from a other register nurse reporting an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that an unknown date, an unknown number of patients were administered ZOSTAVAX that had been improperly stored. No adverse effects reported. This is one (1) of three (3) reports from the same source (MARRS 1408USA017042, 1409USA006413 and 1409USA006413). Additional information has been requested.
Mild Chest pain.  Sore pectoral muscle also   Plus Heartburn    Have had on and off twinge of  chest pain  started next day in pectoral muscle area
Started with chills, progressed to a headache, then body aches, fatigued, muscle pain, lack of appetite,  lethargy,  inability to concentrate, duration 86 hours (3 1/2 days)
Friday 2-26 had rapid heart rate despite taking ivabradine, fainted 3 times Sunday 2-28. All dysautonomia symptoms increased - sweating, extremities turning purple, syncope, indigestion, etc.
Dizziness, Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Chest heaviness, heart racing, leg cramps, chill, arm soreness. Narrative:  Recommended AT LEAST pcp care for: Chest heaviness, heart racing, leg cramps, chill, arm soreness, dizzy, headache, myalgia, arthralgia, fever 1002., N/V/D. States she took flu vaccine sometime between Christmas and New Years, this was her second flu vaccine of the season as she could not get proof of the October 2020 flu vaccine for Employee Health.
No adverse event; medication error. Moderna was inadvertently administered off-label to a youth before the 18th birthday.
On 02/27/2021 a rash developed on my legs. This has lasted till this day but is improving with the use of Triamcinolone that my dermatologist gave me.
Extreme ringing in ears.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 10Mar2021 at 14:00, the patient experienced extreme ringing in ears. CATSCAN revealed nothing except extreme ringing in ears. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, the patient underwent CATSCAN, revealed nothing except extreme ringing in ears. Therapeutic measures were taken as a result of the event which included tests to figure out what was going on. The clinical outcome of the event extreme ringing in ears was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient given Adult dose of Covid vaccine. Should have been given 5-11 dose  No Adverse reaction
pt recvd vax;exp elevation in blood pressure to 180/106,lasted approx 6 hrs;also felt fatigue & had difficulty concentrating;
Patient suffered anaphylaxis with seizure. Was taken by ambulance to ER followed by inpatient admission.
Patient wife reported that patient suffered an episode of syncope that resulted in an emergency hospital visit and subsequent hospital stay of about 7 days and patient is still not feeling well.
Started with vomiting. After 4-6 hours diarrhea began. Both have continued for about 36 hours now.
Client came to the facility to receive her 1st dose of the Covid19 Moderna vaccine.  The RN vaccinated the client in the left arm at 13:15 with the Covid19 Moderna vaccine (Lot# 027H21B).  However, the RN inadvertently administered the incorrect dosage to the client. He administered a booster dose of 0.25 mls. instead of a full dose of 0.5 mls.  The error was discovered by RN 2 while performing a reconciliation of the available vaccine on the floor.  RN 2 notified the Lead RN immediately.  The Lead RN spoke with the RN and determined the client had only received 50% of the full dose required for dose 1 of the Covid19 Moderna series.  After the Lead RN consulted, it was determined the client would need to return to the facility to receive another 0.25 ml. injection of the Covid19 Moderna vaccine.  The Lead RN called the client at approximately 13:35 and explained what happened.  The client was very understanding, stating she had just driven out of the parking lot and would return to the facility to be re-vaccinated.  By 13:48 the client returned to the RN?s vaccination station, and the RN administered 0.25 mls. of the Covid19 Moderna vaccine (Lot# 027H21B) into the clients right deltoid.  Afterward, the client was directed to the observation area to sit for 15 minutes.  No reactions were noted.
I?ve had chills and a slight fever since waking up this morning. 10/26/2021
1. Strange taste in mouth 2. Strange feeling in mouth. ( SLIGHT feeling of numb tounge. Similar to when novicane is almost wore off)  I became very thirsty.  Craved water. 3. Began to resolve/ did not get worse. 5-7 min after onset, as I was reporting to the nurse at the viewing station. By 5pm that evening the sensation was totally gone. 4. I mostly felt really good and safe taking this vaccine. Because I am sensitive to chemicals, and do have reactions to the flu vaccine, I had taken 2 aspirin and an antihistimne the day prior to the vaccine to blunt any adverse effect.  Just in case. I was not worried.   5. The only other symptom was getting tired easily, which was listed.
Information has been received from a physician concerning an 8 month old patient who on 18-OCT-2006 was vaccinated with the first dose of rotavirus vaccine (human-bovine). In April 2007, at eight months of age. the patient was in the office to receive the second dose of the vaccine. The patient was not experiencing any known symptoms. Unspecified medical attention was sought. Additional information has been requested.
I had soreness and tenderness around the injection site. On Wednesday after getting the vaccine I had a sore throat and body aches. I tested for three straight days with a home COVID-19 test, with each test showing negative. Most all symptoms have cleared and gone away with the exception of the sore throat; it is lingering. When I called the doctor, I had a telehealth visit and he prescribe TAMIFLU for the symptoms I described to him. As far as I know I have not been exposed to anyone with the flu.
Patients received HPV # 1 6-26-07.  Patient returns 8/30/07 for HPV #2 and says that her legs were hurting - come back 10/23/07 still c/o leg pain labs were ordered all normal.
pt brought to hospital (9/4/21) via EMS after a fall; c/o right shoulder pain, SOB, weakness; positive for COVID; acute rhabdomyolysis due to the fall; started on dexamethasone and antibiotics; given O2 supplementation via NC; dc'd to on 9/10/21 where pt's condition worsened and he was brought back to ED (9/12/21 per death certificate) where he died of respiratory failure due to COVID related pneumonia
This spontaneous report was received from a Registered Nurse refers to 7 unspecified patients of unknown age and gender. The nurse reported that between 27-AUG-2013 and 06-SEP-2013, the patients received unspecified doses (in schedule) of GARDASIL (lot # H021861, expiry: 09-OCT-2015) 0.5 ml, intramuscularly. Nurse stated that the GARDASIL doses were exposed to 31F maximum for total of 1.5 hours cumulatively on 27-AUG-2013. No adverse effects reported. Follow up information has been received from the registered nurse, who stated that after reviewing office records, 4 patients (previously reported as 7 patients) had received the vaccinations. The patient identifiers were given and dates of birth. The patient concerning his report was 12 years old. This case is related with MARRS 1309USA003768, 1309USA012207, 1309USA012208. Additional information has been requested.
Headache, runny nose Tuesday-Thursday then Thur evening started having chest and abdominal pain, the other symptoms went away except for the chest and abdominal pain
Patient stated she had significant bruising & swelling following vaccination.  She said it lasted about a month.  She did not seek medical attention and informed us of this reaction today when she was receiving her second dose.  She stated the person administering the vaccination seemed to have trouble getting the needle to go through the Inject-Safe Barrier Bandage we use so he removed that, then administered the vaccination.  She said the needle was painful entering her skin so possibly the needle was dulled from drawing up the solution.
pt recv vax 5SEP95 & 14JAN97 pt devel chickenpox;
Arm Sores; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) and (batch number 2325S, expiry date 3rd July 2022) for prophylaxis.   On 28th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 28th May 2020, less than a day after receiving Shingrix, the patient experienced fever. On 29th May 2020, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and at the time of reporting  his arm sores and also had fever. She mentioned that the patient was taking antibiotics because he was constantly urinating. The reporter confirmed that the patient had not started the antibiotics at the time he received Shingrix.  He was picking up the prescription for the antibiotic and received Shingrix while there. The reporter consented to follow up.
Patients received 0.25 ml of the bivalent vaccine; No Adverese event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No Adverese event) in a 79-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No Adverese event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No Adverese event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverese event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  Patient was administered with Booster dose. Pharmacist stated she did not realize the vaccine dosage for the booster has been change from 0.5 ml to 0.25 ml.  The patient did not experienced any side effect. She wanted to know if the other half need to be re-administered and what will be the dosage window. Pharmacist does not know if the patient were taking other medication. HCP was not aware of incident.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644400 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644400:Patient - Husband case
Received flu shot in right arm on Oct. 6. On Oct 8 started with an itch in the center of my back which progressed to blisters over several days. On Oct 15 diagnosed with a "classic case" of shingles moving around the left side of body.
Itching at site of injection of Flublok 2015-2016. Itching continues. Rash and redness approximately 4 inches by 3 inches. Hard area around injection site approximately 2 inches in diameter. Fever.
Pain at injection site immediately after injection that lasted for about 30 minutes.  Slight headache that started around an hour after injection and lasted approximately 24 hours.  Next morning felt muscle aches, fatigue and runny nose.  Felt like coming down with an illness.  These symptoms lasted approx. 24 hours after injections.  Felt completely back to normal again by 48 hours.