chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial swelling; red rash on face; short of breath for 2 weeks; stomach cramping; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration on an unknown date (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. On 04Sep2021, the patient experienced facial swelling, red rash on face, short of breath for 2 weeks and stomach cramping. On an unknown date, the patient underwent SARS-CoV-2 test and the result was not reported. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events facial swelling, red rash on face, short of breath for 2 weeks and stomach cramping were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Large local reaction, cellulitis 13x17 cm (red, swelling, warm, tender) swelling same day, worse 36-48 hours, resolving spontaneously without RX by 72 hours. Pt was sat. about 60-72 hrs after injection.
Dizziness, Headache, Tachycardia,  tingling Narrative:  Patient remained in clinic after her inoculation for 30 minutes. She felt fine, after home she started feeling like her heart was racing, sob, and tingling. Sent to ER. States they observed her only and asked if she had anxiety (which she does not).
2/25/10 Pt was seen 2/20/10 seen pv. Received immun 2/17/10 in R arm. She c/o R arm pain that evening and next day. Seen by another MD 2/19, did x-rays, nothing found. She describes the pain as burning, esp face. Then also c/o legs hurting and face burning. She also c/o HA and dizziness. No fainting, no cough or URI, no vomiting or diarrhea, appetite normal, T max 100.2. No physical changes noted on exam except winces with pain on palpation and movement of R arm and legs but from pressure. No skin findings except 3 or 4 <1cm maculopapules, pink on L iliac crest area, no bulla, no pus, no wheals. No redness or swelling of R arm or legs. No swelling of face. Cheeks sl. pink. This was temporally related to the immunization.
pt recvd vax & exp throat swelling, tight chest & rhonchi; pt was seen by MD:
Woke up the morning after vaccine with a stiff neck. Went to the Dr on  April 28th, given muscle relaxers and a tapering dose of prednisone. While on prednisone the pain and stiffness decreased.  After my second dose of the vaccine the stiffness increased, and I also started experiencing vertigo, which was severe at times. I?m still experiencing neck stiffness and vertigo.
Swollen arm, about the size of a tennis ball; Fever of 102 degrees Fahrenheit; Pretty sick/Sick for about a half of a day after receiving the dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Pretty sick/Sick for about a half of a day after receiving the dose), PERIPHERAL SWELLING (Swollen arm, about the size of a tennis ball) and PYREXIA (Fever of 102 degrees Fahrenheit) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Pretty sick/Sick for about a half of a day after receiving the dose), PERIPHERAL SWELLING (Swollen arm, about the size of a tennis ball) and PYREXIA (Fever of 102 degrees Fahrenheit). At the time of the report, ILLNESS (Pretty sick/Sick for about a half of a day after receiving the dose) and PYREXIA (Fever of 102 degrees Fahrenheit) had resolved and PERIPHERAL SWELLING (Swollen arm, about the size of a tennis ball) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees fahrenheit (High) 102 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter. The patient stated that  during the call he  was over 65 years old. The patient stated that he must have had a robust immune response to the prior two doses and stated that his doctor had suggested pre-medicate with Tylenol before receiving the booster shot.   This case was linked to MOD-2021-366108, MOD-2021-366140 (Patient Link).
Adverse effect of other vaccines and biological substances, initial encounter on 2022-12-16.
Informed by mom on 2/8/02 that her child was found dead in bed on 1/19/02 about 33 hours after well child visit and immunizations. No previous by us, last immunizations at 6 months. Mom reports an autopsy is being done. Per coroner's office no autopsy was done in this county.  COD as per autopsy report is undetermined. Info rec'd 4/18/02 states; The decedent was an 18 month old white male who lived with his parents. He was pronounced nonviable by medics at 08:55 upon their arrival at the residence. The child was found by his father around 08:45 to be unresponsive and 911 was called. The child was last seen alive by his mother about 23:00 of the night before when she placed him in bed after returning from a birthday party. The child has a clinic visit on 1/17 when he had 5 immunization shots and treatment for dry skin rash. There was bottles of children liquid cold medicine scattered in the kitchen but according to the mother, the infant had not had any since the last time he was sick, about 2 1/2 weeks ago. COD: undetermined.
Starting 1/4 and continuing through 1/21- Arm very sore and swollen with "knots" near the injection site. Managed with low-dose ibuprofen and "voltaren cream". Saw PCP about ongoing symptoms-considered injection technique as potential cause
I experienced shingles after vaccination.  I had alot of pain for psoriatic arthritis and also had blisters in my stomach and fever. I am still having some blisters in my stomach. I have other symptoms but they are due to not taking my psoriatic medications which caused an increase in my arthritis.  No tests were performed.  I still recovering at the moment.
Mother called and stated that Pt broke out in hives 1/30 post Hep B vax. MD suggested may be reaction to Hep B vax. Doesn't plan to continue series. Missed wk of school.
pt recvd a third dose of Engerix-B @ the time of conception; f/u info from the MD confirmed the pt had a termination;
NOT ADVERSE EVENT: - Patient was given the correct vaccine lot number FT1551 -- however box of previous lot number was scanned instead lot number FL2757 with expiration date of 9/30/22
Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-; Mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025520-2A) for COVID-19 vaccination.     The patient's past medical history included Actinic keratosis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild sore arm). On 22-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-). On 22-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-) had resolved. At the time of the report, PAIN IN EXTREMITY (Mild sore arm) outcome was unknown. Not Provided          No concomitant information was provided. No treatment information was provided. Action taken with vaccine was not applicable. Consent to follow up with safety was given.   This case was linked to MOD-2021-086684 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Followup email received on 24-05-2021 included No new significant information available.
Tennis ball size reaction that is red and warm, 2 inches below injection site on left arm; Tennis ball size reaction that is red and warm, 2 inches below injection site on left arm; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-04292) on 09-Oct-2019, concerning a 63-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.  On 02-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route: intramuscular, anatomical location: left deltoid, batch number: 259808, and expiration date: 31-May-2020] for influenza prophylaxis.  On an unspecified date, the patient developed tennis ball size reaction, 2 inches below injection site on left arm, that was red and warm.  At the time of initial reporting, the outcome for the events of vaccination site warmth' and injection site redness' was not reported.  The reporter assessed the case as non-serious and did not provide causality assessment.  This case is linked to cases: 201905129, 201905130 (same reporter).  Non-significant follow up received via Agency (reference number: SEQ19-05262) on 22-Nov-2019: Additional reference numbers were added. No changes in the narrative.; Sender's Comments: The patient experienced vaccination site warmth and injection site erythema after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related for both events.
Fever of 102.4 despite Tylenol/Advil every 2 hours for 24 hours, accompanied by sweats, chills, body aches. When fever went away, had nausea, headache, heartburn despite eating very little, then just tiredness.
I had my vaccination on 12/07/2022. On 02/27/2023 I started to get a red spot on my left inner thigh. I thought it was a tic bite or insect bite. It started to get bigger and I thought maybe it was cellulitis. On 02/28/2023 my vein was protruding and the spot was hot to the touch. I went to the emergency room and the doctor stated I had a blood clot. I had blood work and had appointment the following day. I had ultrasound on 02/29/2023 and picked up the ELIQUIS. My primary doctor state it was a Superficial blood clot and to stay on the ELIQUIS. I have 5 days left on the prescription. I do get some pain when lifting leg but the spot is gone. The doctor wants to start aspirin after the ELIQUIS is done. Pain level is at a 1-2 out of 10.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On unkonwn dates the patients were vaccinated with improperly stored GARDASIL (lot #, expiration date, dose and route unspecified). No adverse symptoms reported. The temperature excursion for GARDASIL was found to be supported with in-house stability data. This is one of several reports received from same source. Additional information has been requested.
From initial information received from a physician on 10/26/04 regarding an adverse event occurring, it was reported that a 54 year old female patient received her first dose of FLUZONE, lot number U1138AA, administered in an unspecified site on 10/29/03. Reportedly seven days later the patient was admitted to the hospital with complaint of bilateral lower extremity numbness and weakness. She was diagnosed with Guillain Barre Syndrome. The patient's recovery status is listed as not recovered as she remains wheelchair bound.
After initial ROTARIX, screaming with belly pain x 7 days. Spitting up profusely x 7 days.
This spontaneous report as received from a nurse field representative refers to a 61 year old patient. The patient's pertinent medical history and drug allergies were not reported. On 05-NOV-2014 the patient was vaccinated with VARIVAX (Merck) (dose, frequency and lot # were not reported) instead of ZOSTAVAX. No adverse effects were noted. No product complaint was reported for VARIVAX (Merck). Additional information has been requested.
I started developing urinating problems, severe lower back pain, legs went numb from the back pain, and dizzy. I went to the doctor 08/22/2022 and he did a PSA test, digital exam, and back exam. I was diagnosed with prostate cancer, nerve issues in back and weakened disk. Right after the vaccination I had a fever for a couple of days in the 100s. I have been doing physical therapy for my back which is helping.
No adverse events occurred. This Moderna COVID-19 vaccine was administered as an incorrect dose to patient who thought they were due for their 2nd dose of Moderna as she forgot receiving a 1st dose back in January; the dose was given prior to RN realizing the series was completed. Patient was informed of this administration error at the time of vaccination and reported no side effects the following day or at any subsequent clinic visits.
Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
It was reported in a published literature article, that a 7 week old pt with no history of atopy, was vaccinated on an unknown date with a dose of hep B virus vaccine. Secondary therapy included a dose of diphtheria toxoid+Hib conj vaccine+pertussis vaccine+tetanus toxoid and a dose of poliovirus vaccine inactivated. Two hours pot-vaccination, the pt developed anaphylaxis with petechial lesions, cyanosis, dyspnea, and tachycardia. A chest radiograph and electrocardiogram were performed, but no results were reported. The pt was treated with acetaminophen. The pt's outcome was not reported. Upon internal review, anaphylaxis, petechial lesions, cyanosis, dyspnea, and tachycardia were determined to be other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01902, WAES0310USA01903, WAES0310USA01904, WAES0310USA01905 and WAES0310USA01906).
Exactly 10 days later i felt some pain under my left armpit. When i touched i felt a ball that was a little painful and some swelling. Today marks 1 week and a day since i first felt it. I still have some swelling but not much pain anymore. I had a little pain over the weekend though. And its on the the same arm of vaccination.
Approximately at 11:45 I because congested and nauseated.  I vomited 4 times and spent the rest of the night dry heaving.  The nausea subsided with phenergan around 0800-0900 am on 10/9/15. I experienced cough, congestion, and body aches through early Monday morning 10/12/15.
Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.
Arm sore at injection site and soreness in pectoral muscle under injection arm for a week. A week after vaccination, itchiness and redness at injection site for three days.
10/3 Received influenza vaccine. 10/4 c/o funny taste in mouth. 10/6 c/o blurry, watery (L) eye, couldn't blink, drooping (L) side of face. 10/7 Treated w/ Dr Dx Bell's Palsy, tx with MEDROL Dose pak.
Around 730 PM I started chilling and teeth chattering, headache and queasiness began. By 9:00 PM temp was 99.9. Took TYLENOL and Ibuprofen throughout the night. Woke with temp 100. Lethargic, no energy. Continued thoughout the day, temp went up to 100.1 and on 12/28/18 my temp was gone. Yahoo. Arm is red at site of shot. Tender but tolerable. Still queasy.
Pt woke up day after vaccine administration (received only gardasil) with head itching, sides, bottom itching - elbows with rash - roundish red bumps. Pt denied throat symptoms, SOB. Clinician recommended claritin or benadrl until rash is gone plus 1% hydrocortisone to rash bid.
I have a rash on both forearms that has lasted 3 weeks and still is present. I have been using anti-itch lotion.
My blood sugar jumped almost 30 points and has been higher in the morning.  After the 2nd injection on February 20 the blood sugar jumped higher again.  Can't seem to bring it down with same diet as previous to injection.  Meds were the same and have not changed.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt became unresponsive to verbal stimulus and sternal rub within 5 minutes of vaccination. Person immediately called 911 (witness in line at the pharmacy) while (another patient in the pharmacy; a nurse) assisted the RPh and a technician in laying the patient on the floor and elevating her feet, providing ice packs for syncope symptoms, and damp towels for sweating. Patient became responsive prior to EMS arriving and transfer of care initiated upon EMS arrival.
This subject is a 9 month old female, who was enrolled in a Phase IV P3T08 (Daptacel) study. The subject received two doses of study vaccine; the last dose prior to the event was given on 12/27/02. The subject died of multiple system organ failure due to near-drowning, 163 days post-immunization. The event of drowning was reported by the investigator as unrelated to the study vaccine. Autopsy results are pending. From additional information received on 11/4/03 from the autopsy report: It was determined by an investigation that an autopsy would be necessary to establish the cause of death. Based on the known circumstances and cause of death, the manner of death is an accident. The drowning occurred in a wading pool. Follow up on 11/25/2003: "Information has been received from an investigator concerning a 9 month old Hispanic female patient who was enrolled in a phase IV diptheria toxoid/pertussis vaccine/tetanus (DAPTACEL) study.  On 12/27/2002, the patient was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  Concomitant vaccination on 12/27/2002 included a second dose of diphtheria toxoid/pertussis vaccine/tetanus (DAPTACEL), a dose of poliovirus vaccine (IPOL), a dose of Haemophilus influenzae vaccine (+) tetanus toxoid and a dose of Streptococcus pneumoniae vaccine (PREVNAR).  163 days post vaccination on 06/08/2003 at 15:52, the patient died.  The cause of death was "multi-organ failure due to near drowning."  Autopsy findings included: heavy lungs with hypostatic pneumonia and diffuse alveolar damage; ischemic encephalopathy; thymic involutional changes; congestive hepatomegaly; generalized visceral congestion; minor contisions of legs.  External examination revealed a normally developed, adequately nourished Hispanic female infant who appeared consistent with the reported age of almost ten months.  Internal examination revealed histology-sections of all major viscera were submitted per the SIDS protocol; X-rays-total body X-rays showed no recent healing fractures or bony malformations; "evidence-none"; CNS-vascular congestion, interstitial edema, diffuse changes of ischemic neuronal necrosis; lung-advanced changes of diffuse alveolar damange (hyaline membrane disease) with patchy acute pneumonia and scattered small airways filled by PMN's, interstitial emphysema, one section of right lung showed consolidation by frank acute purulent bronchopneumonia, a section of trachea showed mild chrinoc mucosal inflammation; larynx-chronic mucosal inflammation with focal acute inflammation and necrosis, mild chronic mucositis also noted in epoglottis; no significant histopathology in the heart, speen, pancreas, bone marrow, adrenal lymph node, pituitary, diaphragm, submandibular gland, liver, kidney, fallopian tube or ovary.  The case is closed.  The event of drowing was reported by the investigator as unrelated to the study vaccine. Other business partner numbers include 10380574, 2003-01431, P3T08.  Additional information is not expected.  This report no longer meets the criteria for submission because the relationship to study therapy has been changed."
Vaccine administered at 10 am at 10:30 patient returned and reported pruritis to face, tongue, swelling, throat felt thick. 50 mg Diphenhydramine IM at 10:38. Patient reported symptoms resolved.
PT GOT DIZZY AND NAUSEOUS - HAD PATIENT SIT ON THE FLOOR AND GAVE GATORADE AND A CANDY BAR - PT HAD NOT EATEN ANYTHING SINCE LAST NIGHT. PT ALSO DID NOT HAVE ANY WATER SINCE YESTERDAY AFTERNOON - TOLD PARENTS IT WAS MOST LIKELY DEHYDRATION AND NERVES THAT CAUSED BLOOD PRESSURE TO DROP. CHECKED BLOOD PRESSURE TWICE - FIRST READING WAS 98/82 . 2ND READING 10 MINUTES LATER WAS 103/77. SUGGESTED THAT THE PARENTS TAKE HER TO ED TO GIVE FLUIDS AND MAKE SURE PT WAS OK. PER PARENTS THEY TOOK HER HOME AND ARE MONITORING HER BP. IF IT GOES DOWN AGAIN THEY WILL TAKE HER TO THE ED.
Pfizer-BioNTech COVID-19 Vaccine EUA? Presents to the emergency department with syncope.  Patient received her 1st dose of the COVID-19 1/28/21.  She states she felt in her normal state of health yesterday.  However, she was unable to sleep at all overnight.  She took a nap between 5 a.m. and 9 a.m., Upon waking this morning, patient states she felt generally fatigued, had nausea with associated diffuse abdominal pain.  Patient had 1 episode of emesis.  No hematemesis.  Immediately following emesis, she describes 1 to 2 episodes of syncope that occurred while she was seated in a chair.  Patient did not fall or strike her head.  She denies preceding chest pain, shortness of breath, back pain, numbness, tingling, weakness.   Per EMS, patient was awake, somnolent but oriented, with stable vital signs including heart rate of 68, respiratory rate of 18, pulse ox of 90% on room air and blood pressure of 126 systolic.  On arrival to the ED, patient appears somnolent, hemodynamically stable with normal blood pressure, afebrile.  Patient feels symptomatically improved after 1 L normal saline bolus and Zofran.  She was discharged home in stable condition.
10 days after pt received the pfizer covid booster he sustained a stroke and  a DVT.