chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt admitted for DKA, but also has had a sore throat, dry cough, chest discomfort and fevers for 3 days.  Pt found to be COVID positive.
Intense burning at injection site; Hemi facial spasm - Right side; ptosis; Intense burning at injection site/Hemi facial spasm-Right side, ptosis/Both are continuing to this date and have worsened; This is a spontaneous report from a contactable other health professional (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 15Mar2021 12:30 ((at the age of 59 years)) as dose 1, single, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 06Apr2021 12:30 (at the age of 59 years) as dose 2, single, both for covid-19 immunization. Medical history included hypothyroid, hashimotos disease, high cholesterol and headaches, all from an unknown date and unknown if ongoing. Patient had allergies to vantin [cefpodoxime proxetil] and tetanus. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gabapentin, metoprolol, atorvastatin, and thyroid (ARMOUR THYROID), all taken for an unspecified indication. On an unknown date in 2021, the patient experienced intense burning at injection site, hemi facial spasm-right side and ptosis. It was reported that, the events were continuing till date and had worsened. Since the vaccination, the patient had been tested for COVID-19 and underwent lab tests and procedures which included nasal swab test: negative, on an unknown date in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and patient received treatment with increased amount of gabapentin. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 10 months 30 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
December 30th- chills, body aches January 3rd, swollen subclavicular lymph node.  Swollen lymph node is still present s/p 2 weeks.
Irregular, prolonged, heavy menstration with clots lasting greater than 7 days.
The initial case was missing the following minimum criteria: unidentifiable patient: Upon receipt of follow-up information on 14Sep2915, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician via a Pfizer sales representative. The medical assistant reported six reports for six patients. This is the second report. A 20-year-old male patient of an unspecified ethnicity received second dose of TRUMENBA (Lot# J28923, exp date Jun2016), intramuscular in the left deltoid, on 18Aug2015 at 09:58 am, at 0.5 ml single. Relevant medical history included asthma. Concomitant medications were not reported. The patient previously received first dose of TRUMENBA, intramuscular in the left deltoid, on 02Jun3025, at 0.5 ml single. On an unspecified date the patient had extreme arm pain where the vaccine was injected, like to the point that could barely lift the arm described it as dead arm which lasted about 7 to 10 days after the injection. The reporter considered that the adverse events were due to TRUMENBA. Follow-up attempts completed. No further information expected.
Pt recvd vax 1MAR91, early am of 2MAR pt tearful, unconsolable, felt hot-given APAP by mom; seen by MD on 2MAR, t104, rash on whole body rash x 3 days, ATB discontinued; pt severely lethargic x 2 days;
Moderna COVID-19 Vaccine EUA  At approximately 9:00pm on the day of my second dose I experienced some dizziness. At approximately 12:30 at night, I woke up due to the pain I was feeling all over my body (in particular in my joints and lower back). I also have a severe headache. At approximately 2:30am I experienced nausea and some vomiting followed by chills without fever. The headache, body aches, and extreme exhaustion continued until approximately 9pm the day after the shot. Two days later, almost all symptoms were gone (I still felt tired). I had a small red spot at the injection site that lasted 2 days but the injection site pain was way worse for the first shot than the second one.
3 days of arm tingling, weakness b/l rt more than left, also rt leg weakness, but pt got PCV13 on left shoulder. Symptoms started 5 hours after vaccination. No fever. Symptoms improved 90% today.
Bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiry date not reported), intramuscular in the right arm on 04Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included norethisterone (CAMILA). The patient previously took erythromycin and experienced allergies. On 10Jan2021 at 2:00, the patient experienced bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
Left Ear Lobe swelling, temperature 103. Went to ER at 6:30p.m. given Benadryl.  11/03/15 swelling below ear, forehead, temperature 103, went to ER again, prescribed prescription Benadryl, antibiotic and ibuprofen.  11/04/15, swelling now into eyelids and left ear, temperature 94.3, went to ER and Dr. determined swelling caused from flu shot - continue taking antibiotic and prescription Benadryl.  11/05/15, swelling now below right eye on cheek.
PATIENT ADMITTED TO Hospital 9/14/21 TO 9/16/21 WITH ACUTE LEFT ARM DVT REQUIRING EMERGENCY LOCAL CATHETER DELIVERY THROMBOLYSIS AND THEN ORAL ANTICOAGULATION.  DISCOVERED TO HAVE UNDERLYING THORACIC OUTLET OBSTRUCTION AND IS BEING CONSIDERED FOR SURGERY AND CURRENTLY ON EXTENDED USE ORAL NOAC.  EXAM 11/1/21 SHOWED THE ARM WAS MILDLY SWOLLEN WITH ECCHYMOSES OF THE LOWER VOLAR FOREARM AND DECREASED RADIAL PULSE.  SHE SHOULD NOT COMPLETELY FLEX HER ARM DUE TO PAIN AND SWELLING.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 15 September 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route and injection site). Her last menstrual period was on 11 February 2014 and estimated date of delivery was on 10 November 2014. The subject was exposed to the vaccines during the last trimester when she was 32 weeks pregnant. The conception was a normal one (no in-vitro fertilization used). No adverse events were reported. At the time of reporting the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: The VAERS details and some of the patient's details were provided.
Patient called on 7/3 and reported that after receiving Rabies vaccine dose #3 yesterday his arm swelled and his whole body ached. Stated he felt "like a truck hit me last night." States pain radiated from his arm to the rest of his body. No fever or chills. Today when he woke up his cheeks feel "tingly." Not painful but tingly. Advised to contact physician for advice. He mentioned he had a slight earache when he received the vaccine. At 2:45 pm on 7/3  patient called and said his physician advised him to go to ER. He stated ER physician said it was probably a reaction to the vaccine and come back if it got worse. Patient states his toes are tingly now. He stated that the ER physician discussed the risk vs. benefit of the vaccine and recommended that he complete the series. The patient was scratched by a wild cat. He went to a public health hospital on 6/21 and received IG and vaccine. On 6/24 he was in another part of the country and went to the public hospital and receive what he described as a large amount of fluid in the gluteus. Because there was no documentation as to what he received, it sounded like it could have been another dose of IG, that was not counted as part of the post exposure vaccine series. He received what was considered dose #2 rabies vaccine on 6/28 with no problems. He subsequently received dose #4 on 7/9. He reported no problems after that vaccine.
Vaccination site erythema; Vaccination site swelling; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, ESCITALOPRAM OXALATE (LEXAPRO), ALPRAZOLAM (XANAX) and TOPIRAMATE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown. Not Provided      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.   Treatment details include Advil, Benadryl cream and Ice.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Added additional reporter detailsAdded concomitant medication (LOSARTAN)
My left hand started to hurt at the very base of my thumb (the part that is almost close to the palm). It started out with very mild pain (1 of 10) and as the day and night progressed, the pain was constant and became increasingly more painful (7 out of 10). It woke me up in the middle of the night. That specific part of my hand was throbbing and very painful and it spread to the rest of my hand. I have a small amount of redness and tenderness on that spot. I woke up the following morning (today) and I could not bend my thumb without it being very painful. I did not do anything to injure myself and I don't have a history of hand pain or thumb pain.
Patient had an adverse reaction to 6months old vaccination on August 31st,2020.She developed fever of 103.1F within 2 hours of being injected. That afternoon she slept so deeply that I almost have to shake her up in order to breast feed her which she refused to  do that anyway. I didn't sleep all night and keep checking on her if her condition hasn't worsen. She woke up the follow up morning vomiting profusely. I called the pedestrian office to make the following appointment. The office was giving me hard to to schedule the appointment claiming that potentially she might of contracted Covid-19. That wasn't the case. Doctor did  see her, but she was very short with me stating this perfectly normal. Patient's fever continued for another 6days.  All that time she barely ate anything and drunk very little. She was very lethargic. Shortly after she developed stiffness in her left arm. I had a hard time dressing her up without hurting her. Her arm became very weak and she couldn't bear any weight on it. Because of that she missed developmental milestones. Wasn't able to crawl till 13 months and started to walk at 21 months.
I?m menopausal and have not had a period for many months. On 7/5 a strong sudden period with strong cramps started. Previously I didn?t not have cramps. It was strong enough to bleed through pads within hour.   On day 5 it?s even stronger and my prior periods would be diminishing by day 4. I have also felt tired, achey, nauseous but it?s manageable.  Just want to report because this was abnormal experience.
Information has been received from a registered nurse concerning a 6 month old patient who on 13-JUL-2010 was vaccinated with a dose of PNEUMOVAX 23 (0.5ml, lot # 662842/1296X) instead of a dose of PREVNAR by accident. This was a medication error. No adverse effects were reported. Additional information has been requested.
Patient requested the Bivalent booster, his fourth COVID shot. The medical assistant incorrectly drew and injected him with the original vaccine series. Patient will be notified and re-vaccinated as recommended.
Tongue pain, throat tightness, subjective dyspnea starting 1hr after vaccine administration. No urticaria, pruritus, objective tongue/lip/throat swelling, wheezing, hypoxia, hypotension. Given BENADRYL, ZANTAC, prednisone PO. No change in tongue pain but throat tightness and dyspnea resolved over 1-2hrs.
L deltoid erythema from 8/26/03 and progressively enlarged to 10x6cm induration. Resolving by 8/29/03. Totally resolved 9/2/03.
A 62yo B. female with PMH of Knee Pain, Proctalgia, Hyperlipidemia, Shoulder Tendonitis and Depression. On January 26, 2022 hospital attending physician reported the patient had a historical ADR of Pfizer Covid -19 booster vaccination included Muscle pain, described as right sided severe chest wall pain which lasted for few hours and self resolved. The patient's secure messaging to the MD included she took the Covid vaccine booster on January 24,2022 and experienced fatigue chills and chest pain the following day.
On 08-APR-2021 (1 day after first vaccine): experienced headache/fatigue/difficult concentrating On 16-APR-2021 (9 days after first vaccine): experienced a sudden reaction at the injection site. The area became swollen, red, hot to the touch, itchy, and painful. The affected area was approximately 4 inches in diameter, surrounding the injection site. Medical attention was not sought. Discomfort was treated with icing of the area. The symptoms resolved at approximately 24 hours after onset.
WITH IN 2-3 MINUTES OF VARICELLA VACCINATION IN THIGH, REDNESS, SWELLING, LOCALIZED REACTION.  GIVEN ICE PACK.  PHYSICIAN NOTIFIED.  PATIENT OBSERVED FOR ADDITIONAL 15 MINUTES.  NO ADDITIONAL SX'S.  INSTRUCTED PARENTS TO WATCH.  CALL OR TO ER IF SX'S CHANGE.
Inflammation of a sebaceous cyst that had never been inflamed before (I've had it for several years) after both doses of the vaccine.  (First dose is the date stated in the form filled out, second dose was exactly 4 weeks after the first dose.)  The cyst is close enough to the vaccine site that it was included in the localized inflammatory reaction I experienced after both doses.  It became inflamed shortly after the first dose, and became increasingly inflamed (after seeming to stay the same or die down in the intervening 4 weeks) within 48 hours of the second dose.   Inflammation was above and beyond what surrounding "normal" tissue experienced, and lasted longer.  Initial response after first dose was occasional "weeping" of clear fluid (not pus) and occasional slight tenderness.  Response after second dose has been a continuation of the occasional clear fluid, plus slight additional swelling and moderate to severe pain that has subsided to moderate to mild pain since 48-72 hour mark.  Does not seem to be infected, but is still inflamed after vaccine response. I already have an appointment to have it excised next month, and am not overly concerned about this, but thought the reaction was enough to merit reporting in case others are experiencing similar prolonged inflammation for similar or other dermatological conditions near injection sites.
11/17-received preservative free vaccine. 11-18-area of injection red, warm to touch, sore. 11-19-reddened area increased size, swollen, hot to touch, painful to touch. (11/20/14-red, warm (5 inch x 6 inch). 11-20-14-area still reddened, sore and warm to touch. Feeling increased HR, increased anxious, general malaise. Stated noted similar reaction last year.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine product.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 13Feb2021 as dose 2, single (Lot number: EL9267), in left arm and on 22Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Interchange of vaccine product."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2022) negative, notes: took rapid antigen tests every morning and night since then and tested negative on the night of 16Nov; (19Nov2022) Positive, notes: I have continued to tests morning and night. I am now positive on two antigen tests on the morning of 19Nov. Therapeutic measures were taken as a result of vaccination failure, covid-19.
The pt's left arm began to swell shortly after receiving the vaccines. The pt saw an internist on 12/20/00. The pt was treated with Benadryl and Allegra. The arm continues to itch and the swelling is decreasing.
This spontaneous report as received from a healthcare worker refers to a 13 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient presented to the Observation table with c/o chest tightness. Notes she has a hx of cardiac stent and angina but notes this pain/pressure feels different than her typical chest pain.   Also reports a hx of COPD. Vitals: B/P 149/90, HR 95, o2% 95. Patient was escorted to the stretcher and was provided with water to drink. Code Medic was called. Team arrived and patient was transported to the ED for further evaluation.     Upon arrival to ED the patient's vital signs were unremarkable, due to patient's extensive cardiac and medical history (CAD s/p PCI to LAD (2016), HTN, DM, and COPD) patient was evaluated and cardiology consult obtained.    She received a dose of aspirin, ketorolac and nitroglycerin in the ED.    EKG without acute changes and troponins negative, patient discharged home after 4hrs
Site: Redness at Injection Site-Mild, Systemic: see notes-Mild, Error: Patient accidentally stuck by needle. Additional details: As provider was pulling out the needle from patient's thigh, patient slapped his hand across the syringe and caused needle to scrape the top of his thigh. Superficial scrape about 1 inch in length with minimal bleeding. Band-Aids applied. No other adverse effects noted. Patient's father stated he will apply Polysporin at home and clean the area. Encouraged parent to monitor and follow-up as needed. Patient scheduled in 21 days for 2nd dose.
My body was aching and throbbing. My back, legs, and hands feel like they swell sometimes. Sometimes it feel like my heart will flutter. Sometimes I cant grip anything. Every now and then I would get a headache. Sometimes it was hard to breath as well. My sex drive went down after catching COVID in March 2020. When I had caught COVID, before getting the vaccine, I couldn't breath and I was hospitalized for a month. And every now and then my legs will start throbbing.
Shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On around 24-MAR-2015, the patient was vaccinated as prescribed with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and/or zoster-related conditions (dose, strength, route of administration, expiration date and lot number were not reported).  On an unspecified date, the patient developed shingles and was treated by a doctor in an hospital. According to reporter, as a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of pre-existing conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future.  At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).
The day after receiving vaccine, patient  had a low-grade fever and when she got into the shower she "passed out".  Mom heard a noise and found her on the bathtub floor.  Patient was conscious and remembers event.  Hit side of head on tub.  Mom took her to ED and there her EKG was normal and she was dx with syncope  and sent home. Today patient returned to our clinic for f/u from ED visit.  She still had a low-grade fever (100) and mild headache.  I noticed her left deltoid area was erythematous, warm to touch, and edematous covering the entire deltoid area.  There was also a 1 cm ecchymosis noted on upper left deltoid (assuming where needle insertion for one of the vaccines).  I encouraged dad to alternate ice and heat to left upper arm and gave an rx for Keflex if redness and swelling worsened over the weekend.