chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had this vaccine, shingles outbreak / suspected vaccination failure; shingles outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not applicable for this report. The reporter stated that none of his or her friends who had this vaccine had been safe from getting a shingles outbreak. The reporter requested that there were antiviral drugs you could take, that greatly reduce the possibility of another shingles break out. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Information has been received from a licensed practical nurse (LPN) concerning a 4 year old female who on 01Sep2000, was vaccinated with a dose of varicella virus vaccine live. The LPN reported that in April 2003 the pt presented to the physician's office with a rash. The pt had approx. 25-50 lesions on her turso and buttocks. A diagnosis of chickenpox was made. At the time of this report, the outcome was unknown. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GT2524) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 15May2023 to unknown date in May2023.
I have a really sore throat and pains in my lower calf muscles. I have been taking tylenol every 4 hours since yesterday
Initial and follow-up information has been received from a health  professional and a consumer concerning her 21 year old daughter who was a student, with a penicillin allergy and a hypersensitivity to canvas who, on 24-MAY-2007, was vaccinated IM in the deltoid with the first dose of Gardasil (lot # 657622/0388U) via injection. There was no concomitant medication. On 24-MAY-2007, (previously reported as 25-MAY-2007) the patient experienced hives, welts all over after receiving the first injection of Gardasil. The patient had been on CLARITIN and had taken steroids (dose, duration, and route not reported) to alleviate the symptoms. As long as the patient continued the CLARITIN, the symptoms subsided, but as soon as the CLARITIN was discontinued, the hives returned. The patient was referred to a dermatologist to test for environmental allergens which may have caused an "incidental allergic reaction." On an unspecified date an allergy test reported no allergens were identified. As of 13-JUL-2007, the patient had not recovered from the hives and welts all over. Additional information has been requested. The reporting health professional considered hives and rash to be other important medical events. Additional information not expected. At the time of the report the patient had not recoveed from the hives and a rash.  The reporting health professional considered hives and rash to be other important medical events.  Additional information is not expected.
Moderna booster following previous Janssen vaccination and prior infection at the start of the pandemic. Person described back pain, fever, and swelling/discomfort of testicles.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patient's medical history, concurrent condition nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly COMVAX, (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provide any further details at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
family describing pt as not acting right day p/vax 3MAY98;then Aunt described pt as trembling;twitching;became unconscious w/eyes rolled back & drooling x 10min;not seeing well;confused;
Acute onselt of right sided chst pain; non-exertional.  Seen and evaluated in emergency department.
Red rash at injection site(2in diameter), swelling at injection site, pain at injection site, touch sensitivity at injection site, skin warm to touch at injection site,  hard bump at injection site/ Treatment consists of ibuprofen, cold compresses, resting of arm/ Event still in progress(Day 3)
A week after receiving the covid vaccine I started to experience numbness in my left arm that would start in the shoulder and radiate down to my pinky and thumb.  This numbness was off and on and still persists today, almost two months after the shot.  The second week after the shot I started developing chest pains around the heart that intensified as the days went on.  I also had shooting pains in my heart.  I ended up visiting the ER on September 22nd as I was concerned I was having some sort of cardiac event.  Several tests were run and I was discharged to go home and consult with a cardiologist.  I began taking ibuprofen which seemed to offer some relief.  I spoke with my primary care doctor and he reviewed my test results and suggested everything was fine.  I had pushed for an echo in the ER and they would not do it.  So I asked him if he thought it was a value and he ordered one.  On October 1st I had an echo cardiogram done and according to my doctor there was no significant findings.  I did however have a low EF 50-55% which seems low for a triathlete like myself.  My doctor again suggested things were ok and I pushed for a stress test which he agreed to.  I did not do the stress test but I set up an appointment with a cardiologist to find out what is going on.  I had the appointment on October 18th and after speaking with him and having look over all my test results he determined that I most likely have pericarditis that at the top of the list of causes is the recent covid vaccine.  He said the numbness in my arm could also be caused by the inflammation around my heart.  He prescribed that I up my dosage of ibuprofen to 1200mg/day and follow up in a month.  I am a healthy active adult who trains and races in triathlons.  I had no health issues leading up to the covid vaccine.  Since getting the covid vaccine I have been dealing with chest pain around the heart and numbness in the left arm that radiates down to my fingers.  Taking ibuprofen seems to offer some relief.  I am not sure how long these conditions will persist and am concerned about the long term outlook.
approximately 10 minutes after her first Pfizer vaccine pt starting feeling a "Cotton Feeling"in the back of her throat.Pt states her tongue felt slightly swollen in the back. No lip swelling, no hives .Pt brought back for observation. Initial vital signs:BP 121/84.Pulse 80, Pso2 96% Resp:18. Pt denied difficulty breathing. Benadryl 25 mg and Pepcid 20 mg given to pt at 1403. Pt observed for over 30 minutes. Pt stated she was feeling better prior to dispo. Pt's husband drove pt home . Allergic reaction discharge instructions given to pt, pt verbalized understanding.
site of injection swelled up a little, it is not painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (site of injection swelled up a little, it is not painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (site of injection swelled up a little, it is not painful). At the time of the report, VACCINATION SITE SWELLING (site of injection swelled up a little, it is not painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient wanted to know if he can apply alcohol on his arm after receiving the Moderna COVID 19 vaccine.  Concomitant medications were not reported. Treatment information was not reported.
Patient had mild tongue swelling after 5 minutes of vaccination, she took 25 mg of benadryl as a pre-medication and also repeated this when the symptoms started. She has a history of anaphylaxis to vaccinations.
Bilateral upper and lower extremity myalgia with paresthesia, Diarrhea, loss of appetite
MONTH LONG PERIOD, FOLLOWED BY PAINFUL CRAMPS, SPOTTING, AND NOW ON MY SECOND LONG PERIOD. HEAVY CLOTS AND PAINFUL CRAMPS.
This spontaneous report was received from a physician, via a company representative, referring to a male patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. Approximately in 2001 (reported as "15 years ago"), the patient was vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On an unknown date, the patient experienced an unspecified problem with his testicle. The patient was remitted to an urologist. The outcome of testicular disorder was unknown at the time of this report. The reporter did not provide a causality assessment between the event and therapy with M-M-R II. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2007, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster.  In 2010, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt received #1 MMR on 12/30/2009. Pt developed fever to >104 F on the night of 01/06/2010, rash started on 01/07/2010. Generalized erythematous maculopapular blanching eruption involving palms and soles. CBC, BCx Supportive Care provided.
Information has been received from a physician concerning a female who reportedly received her first dose of GARDASIL in her left arm, intramuscularly, around the week of 21-JAN-2008. Since receiving the vaccine, the patient had refused to move her arm and continued to carry it close to her body. The physician reported that the patient began experiencing neuropathy, swelling and injection site redness in her arm and by the end of the third week, she was sent to a neurologist. The physician reported that the patient was now going to physical therapy for her arm because she was still refusing to move it. No lot number was provided. Additional information has been requested.
Two days post vax, the pt's head felt sloshy, like cotton, she had sore throat, chest congestion, a cough, and difficulty breathing. She could not seem to take in a deep breath. The difficulty breathing felt worse with activity. Additionally, she had a little bit of numbness in the ball of her left foot, and extreme fatigue. She described her legs as feeling like lead. No treatment given.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Date of refrigeration was reported as 7-May-2021.   This case was linked to MOD-2021-363732 (Patient Link).
Pfizer Dose 1 1/25/21 (EN5318) Pfizer Dose 2 2/17/21 (EN5318) COVID Positive 1/29/22  1/29/22: Patient is a 92-year-old male who presents to the emergency room via EMS with complaints of generalized weakness and a fall at home.  Patient states that he fell at home and laid on the ground for roughly 5+ hours.  There had been some complaints of chest pain which the patient is currently denying.  He denies any shortness of breath or dyspnea on exertion with no cough or sputum production symptoms.  He denies any abdominal pain complaints. Patient states that the weakness complaints are ongoing and are not new.  Patient did not hit his head and states that the reason for his fall was that he just weak in general. The only changes to his medical regimen have been that 1 of his blood pressure medications discontinued.  Patient is a do not resuscitate and had actually been considering hospice care recently.  In reviewing his chart it does look like a palliative care referral was made.  Patient's code status was clarified and he confirms that he is a do not resuscitate.  The patient's medical history, current medications, imaging studies, vital signs, laboratory studies and emergency records were personally reviewed. Case was also discussed read with the emergency room provider.  Patient was treated recently for pneumonia with today's chest x-ray showing worsening pneumonia.  2/3/22: 92-year-old male patient with a history of chronic atrial fibrillation, BPH, chronic back pain, hypertension, type 2 diabetes, depression, dementia would to the hospital on 1/29/2022 after he sustained a fall at home due to generalized weakness.  Patient was at home for more than 5 hours prior to the arrival to the emergency room.  Patient was noted to have pneumonia and started on antibiotics. Patient was given IV fluids for elevated CK levels which significantly improved.  Patient has chronic renal failure which is superimposed with acute renal failure due to his fall.  Patient was going to fluids and his kidney function returned to his baseline at the time of discharge.  Patient was tested positive for SARS-CoV-2 virus.  He did not require any at the time of discharge.  Patient was recommended to be transferred to a skilled nursing facility upon evaluation by PT/OT.  Patient will be transferred to the nursing home. He will follow up with primary care physician in 1 week.
Immediately - I just had moderate fatigue the day after the vaccine - and it was gone after the following day. No treatment. I started having chronic hoarseness in March. I had a visit with the doctor's partner and she came in on that same visit - on May 17th. I had a laryngoscopy that day and that is where they found the vocal chord nodule. I had surgery on the 26th of May to have the nodule removed. They did a pathology and a culture and it was HPV related and found that it was cancerous. I am still getting monthly surveillance as I had vocal chord cancer - monthly scopes. I have developed scarring and some inflammation. The voice is better but it's not where it needs to be. New med: Omeprazole - 20 mg twice a day -to make sure they can keep from getting acids on the vocal chords so they can heal (I had a diagnosis of reflux.)  I was also diagnosed with Melanoma in February on my left arm. I had an incision of that and that was done on February 1st - Melanoma In situ. I will start speech on August 10th. April 20th - I had a physical with my primary care doctor and that was fine.
pain in right foot that because calf cramps  - showed up few days after first shot; with second shot - became knee pain and then it moved up the inside of my thigh from my knee; went to doctor for pain and movement and had urgent ultrasound where they found large blood clot in my leg; had to start taking highest dose of blood thinners and seeing a hematologist; have had blood work done 3 times now and having my second ultrasound and more bloodwork in January to see if the blood clot has dissolved
Tingling in hands and feet, face was tingling; Dry throat; Face is tingling and red; I am having some real bad side effects; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hands and feet, face was tingling), DRY THROAT (Dry throat), ERYTHEMA (Face is tingling and red), ADVERSE REACTION (I am having some real bad side effects) and MYALGIA (Body Aches) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (Tingling in hands and feet, face was tingling), DRY THROAT (Dry throat), ERYTHEMA (Face is tingling and red), ADVERSE REACTION (I am having some real bad side effects) and MYALGIA (Body Aches). At the time of the report, PARAESTHESIA (Tingling in hands and feet, face was tingling), DRY THROAT (Dry throat), ERYTHEMA (Face is tingling and red) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients. Patients' pertinent medical history and concurrent conditions were not reported. On multiple unspecified dates ranging from 12-JAN-2016 through 19-JAN-2016, improperly stored VARIVAX (Merck) were administered to multiple unspecified patients, lot # L028275 and expiration date 28-JUL-2017 (strength, dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported and no product quality complaint was involved. The nurse reported the temperature excursion. Temperature: every day cycles lasting up to 6 minutes each ranging temperature from -13.6 C degree to -14.5 C degree. Time frame: total 54 minutes cumulative Outcome of the excursion: VARIVAX (Merck) was supported until expiry. Additional information has been requested.
Inadvertently given Pfizer Bivalent instead of Pfizer monovalent as 1st shot in primary series. Advised to complete the series with monovalent in 21 days to complete the series.
At 6:00 PM I started to sweat and got a fever of 100.5 I was starting to feel very tired. On Thursday 7th I was unable to go to work as my body was extremely weak and fever was 100.9. Friday 8th I was very weak with body ached and headache I was able to work then, Saturday 9th I was in bed all day with extreme fatigue headache and nausea. Sunday 10th was better with backache and headache.
patient was administered expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 11-Aug-2021 from an Other health professional via Global Medical Information (GMI) (Reference number- 00719846) and transmitted to Sanofi on 11-Aug-2021.  This case involves a four-month-old male patient reported that patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 10-Aug-2021, the patient received 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ398AA, U6872AA and expiry date 06-Aug-2021, 01-Feb-2022] via intramuscular route in right thigh for prophylactic vaccination.  It was reported that, "Medical assistant reports patient was administered expired vaccine on 10AUG2021. It expired 06AUG2021".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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 by the regulatory authority. 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.
pt c/o bumps on lt side, initially painful when pressure applied;sl itchy;bumps noticed late same day recv vax;shot given in rt arm;symptoms abated after 6 wks.
itchy @ site w/in 5min of inj;then 4x4 area of redness no systemic rxn;