chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient at site for 1st dose of COVID Vaccine.  Patient approximately 2 minutes after receiving vaccine at 1028 started feeling tongue swelling with throat itching.  Patient taken to first aid room where she was assessed by provider and ems on duty.  Patients skin was red and flushed and with slight swelling of the tongue noted.  Patient still A7 O x4 with respirations even and unlabored.  Patient had O2Sat of 96% on RA.  Patient states she has an allergy to all Bovine proteins and had a mini-stroke approximately 4-5 years ago.  Patient is a healthcare worker and is currently at home with newborn son.  Provider ordered Benadryl 25mg PO and pt received 1st dose at 1045.  Then provider ordered a second dose of Benadryl 25mg after patient stated her Jaw felt "Wonky" and patient received at 1048.  Pt slowly responded to treatment and after 15 minutes from first dose of Benadryl patient had a decrease in redness and tongue swelling.  Itching was slowly decreasing. At 1105 patient stated itching had subsided and by 1110 patient had a full return to baseline.  Pt discharged at 11:15 home and pt communicated understanding that she was ok to drive and that she should follow up with PCP prior to receiving second dose of vaccine.  Also, patient was able to communicate understanding of a rescue plan at home if symptoms should flare up again.  Patient stated she did have an epi pen at home as well and note if she needed to she would use epi-pen and seek immediate medical attention after use.
tia; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (tia) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had a lot of chronic problems.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 2) and COVID-19 VACCINE JANSSEN (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and COVID-19 VACCINE JANSSEN.    In 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In August 2023, the patient experienced TRANSIENT ISCHAEMIC ATTACK (tia) (seriousness criterion medically significant). The patient was treated with SIMVASTATIN (STATIN [SIMVASTATIN]) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (tia) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that She did not had any problem with the Moderna vaccine but now she had been hearing that the new Moderna vaccine was made differently. She said that the RNA right now was different. She was concerned about the safety of the new vaccine. She also had Transient ischaemic attack (TIA) on unspecified date of Aug-2023 and was on statin and aspirin.   She also stated that she heard that a lot of people are dying and having a stroke from the vaccine. She also heard about a 38 year old person who dies after getting the vaccine although she was not sure whether it was Moderna or another brand.  Company Comment This spontaneous case concerns a female patient of an unknown age with medical history of Previously administered products COVID-19 VACCINE JANSSEN (2 doses) and with a lot of chronic problems who experienced the seriousness criterion medically significant unexpected AESI of transient ischaemic attack (TIA)  the following year after 3rd. dose of SPIKEVAX NOS vaccine. As the patient received doses of Vaxzevria vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case. At the time of the report, the event´s outcome is unknown. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
SUBJECT: CALL TO FEE DEPT               R'CVD. CALL W/VOICEMAIL MSG.@ 1:16PM, CALL RETURNED AT 2:38PM AND WAS INFORMED BY UR NURSE, THAT THIS PATIENT HAD A SERIOUS REACTION AFTER THE FLU SHOT HERE YESTERDAY. S/S CONSISTED OF HIVES OVER HIS BODY, ANGIOEDEMA, LIPS AND NASAL SWELLING AND CHEST PAIN. HE WAS TREATED AS SUCH: IV SOLUMEDROL, IV BENADRYL, IV TAGAMET, IVF, DUONEBS FOR WHEEZING (DID NOT PROGRESS TO STRIDOR). HIS CP IS BEING RULED OUT, HE IS TO HAVE A STRESS TEST. PATIENT ALSO HAS ELEVATED D-DIMER.  PATIENT HAS BEEN PROGRESSED TO PO MEDS WITH THE EXCEPTION OF STILL BEING ON IV SOLUMEDROL.  9/29/09 Hospital and  ED records, DC summary, received DOS 9/22/09 to 9/23/09.  Assessment: Atypical chest pain, asthma exacerbation, allergic reaction. Patient developed hives on arms, legs, back, buttocks, groin area, and abdomen. Lips and nose began to swell.   ICD-9 Codes: 708.0 Allergic urticaria, 493.22 Chronic obstructive asthma with acute exacerbation, E949.6 Viral/rickettsial vaccine causing adverse effects, 309.9 Uspecified adjustment reaction, 786.59 Chest pain, 355.9 Mononeuritis of unspecified site, 272.4 Unspecified hyperlipidemia, 600.00 Hypertrophy (benign) of prostate.
First, pain in my left foot afterward I felt a little ball, that is painful, and it stings
Information has been received from a LPN concerning a 4 year old female with no past medical history or allergies, who on 06/11/03 was vaccinated SC with a 0.5mL dose of MMRII (Lot # 644581/1082M). Concomitant therapy that same day included a dose of DTP and IPV and Augmentin.  On 06/12/03 the pt developed a large, red, swollen area at the injection site of the MMRII that reportedly measured 20x18 inches. Unspecified medical attention was sought. No lab or diagnostic tests were performed. The pt reportedly recovered on an unspecified date. Additional information indicated that the reporter did not think that the site measured 20x18 inches "and if anything it would be in cm and not inches." The reporter indicated that she would need to review the pt's chart "to be sure", and that this was not possible at the time of the report. Additional information has been requested.
Sudden loss of vision, pupil dilated, skin became pale a minute or two after Gardasil shot, pt is alert and oriented. Patient regained vision within a few minutes.  Paramedics came and took blood pressure: 95/57.  1 bag of fluid given and sent home with parents.
Information has been received from the pregnancy registry for GARDASIL from a 23 year old female patient, with no pertinent medical history and no drug reactions/allergies, who on 26-JUN-2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included cephalexin. A few days later after receiving the first dose of GARDASIL, the patient found out she was pregnant. The patient sought medical attention. The last menstrual period was six weeks from 23-JUL-2008 (approximately on 11-JUN-2008). On an unspecified date, was performed a pregnancy test resulting positive. Estimated date of delivery approximately 18-MAR-2009. No adverse reaction was reported. Follow up information received from the patient indicated that on 12-MAR-2009 she gave birth to baby girl. It was reported that the baby had "some problems"; the baby was born with hydronephrosis in her kidneys and had two surgeries. The baby was "doing fine now". Additional information has been requested.
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 07-MAY-2018, the patient was vaccinated with and incorrect stored dose of PROQUAD (lot # N023967 with expiration date on 28-FEB-2019) (strength and route were not reported) for prophylaxis, however no adverse effects reported. Other suspect therapies included sterile diluent. It was reported that the vaccines were exposed to temperature of -3.9 centigrade grades range for a time frame of 1 hour. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
Dull pain, itching, prickly burning sensation at inj site. Wakes me in my sleep to scratch, and sometimes wakes me w/ stabbing pain, so I rub the area. I was given the TDAP vaccine (0.5ml, Lot # U4329AA) on 5/30/2012 for having a metal wire pierce my foot. To this day I am experiencing a dull pain, itching, prickly burning sensation in the ara at the injection site. There is nothing visually seen in the area on the surface of the Lt deltoid where the vaccine was administered (no swelling, not hot with fever, and not red). There is just an uncomfortable feeling in the area of the dose administration constantly.
Initial report was received from a health care professional on 15 November 2012. A female patient (age and date of birth not reported) had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH731AB, on 08 October 2012. On 01 November 2012, the patient developed left shoulder pain and arm pain to hand, left ear pain and knots behind left ear that got progressively worse and a headache. Treatment included steroids and anti-inflammatories. The patient continued to complain of symptoms. Cervical spine and left shoulder x-ray were within normal limits (WNL). The patient had no known allergies (NKA) and no illness at the time of vaccination. Outcome was not recovered. Documents held by sender: None.
Pale, weak cry, pulse 128-but good quality, shock like appearance; no breath holding spell-noted;
Patient's face became pale, tingling in face and mouth, slowed/slurred speech, blurred vision after less than 5 minutes after administration. 911 was called and arrived to take patient to hospital. Patient speech and vision improved right before being taken to hospital.
Office visits 8/21 and 8/22/13. On 8/21 - described as "local reaction" 8/22 with increased c/o pain, vomiting, pain in neck and a 2-2 1/2 in. area of redness to upper arm. Impression was "cellulitis".
2nd vaccine is 3 months overdue; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, 2nd dose was due in May 2021 (6 months), and was 3 month overdue.
Altered sense of taste that has continued through today which which can be described as metallic  without altered sense of smell.
Information has been received from a registered nurse concerning a school aged patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed a mild case of breakthrough chicken pox. Unspecified medical attention was sought, but laboratory tests were not performed and treatment was not required. A product quality complaint was not involved. The reporter also mentioned a second patient who developed chicken pox post vaccination with varicella virus vaccine live (WAES0405USA01135). Additional information has been requested.
Fatigue, severe body aches, arm pain at injection site, chills, high fever (101 degrees Fahrenheit), headache
MAR92 recvd Engerix-B & 2 wks later devel signs of Hepatitis turned yellow, high fever, inc bilirubin); seen by MD; pt still gets tired but is getting better;
chest pain; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. On an unknown date, the patient experienced chest pain after took the second Pfizer Covid shot and wants to know if the patient can be a candidate for trials C4591009 NCT or C4591021 or C4591036. The patient found these studies and want to make sure patient was supervised in a trial environment instead of just taking the third Covid booster shot. The outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Admission Date: 8/26/2022 Discharge Date: 08/31/2022 Presenting Problem: Cardiogenic shock (HCC)  HOSPITAL COURSE: Patient is an 84 year old male with PMH of chronic diastolic heart failure, cardiac amyloid TTR, persistent Afib on ASA only 2/2 hx rectal bleeding, CAD s/p CABG and LAA excision 3/2021, pulmonary sarcoidosis, hypertension, hyperlipidemia, orthostatic hypotension, OSA on CPAP, CKD 3b, thoracic aortic aneurysm, and venous insufficiency.    He was hospitalized July 2022 with SOB and LE edema, ultimately diagnosed with cardiac amyloid based on CMR and PYP scan. He does have hx of Afib but has LAA ligation and with hx of GIB, he was not discharged on DOAC. He was discharged with torsemide, BB, spiro and since been started on tafamidis in the clinic.    Patient saw Dr. as follow up on 8/25 and reported feeling miserable for the last month; DOE, SOB, lightheaded, dizzy. He was scheduled for urgent RHC to assess hemodynamics. RHC on 8/26 showed low filling pressures but cardiogenic shock (RA 8, PA 50/14/24, W 14, FCI 1.2, wt 94.7 kg) and he was subsequently admitted for optimization. He was started on milrinone 0.2. He remained in Afib with elevated HRs, but given exteremly low FCI, his BB dose was reduced and then discontinued. Typically digoxin is contraindicated in patients with amyloid, but discussed with AHF providers, some clinical success with low dose digoxin so he was started on digoxin. Also, given Afib and amyloidosis, it was recommended that he start OAC; he was started on low dose eliquis 2.5mg bid. If rectal bleeding recurs, can discuss stopping OAC again. Prior to discharge, RUE PICC line was placed for home milrinone.  Palliative care saw patient this admission, patient aware of condition and prognosis long term, and would like Hospice to call him next week to set up an informational meeting once patient is home. Patient stable for discharge on IV milrinone at 0.2 mcg/kg/min on 8/31/22.
Narrative: COVID infection following COVID vaccine series 01/28, Pfizer, dose #1 02/19, Pfizer, dose #2 06/01 CR impression: 1. Nonspecific subtle left suprahilar increased opacity. 2. Similar left rib deformities. 07/03 Extremity impression: 1. No sonographic evidence of deep venous thrombosis in the left lower extremity. 2. Superficial thrombosis involving the left lesser saphenous vein. 3. Varicose veins involving the left mid thigh and left mid calf. The above results were communicated to PA at 1:42 PM on 7/3/2021 with read back verification. 08/23 Extremity Impression: 1. No LEFT femoropopliteal venous system deep vein thrombosis. 2. Previously noted superficial venous thrombosis of the left lesser saphenous vein is no longer visualized. 3. Patent superficial varicosities in the left mid calf in the area of reported pain. 11/22 COVID swab, result; detected 11/20 pt cc: cough, diarrhea, rhinitis, sore throat exposure: unknown 11/22 SARS-COV-S Variant Sequencing result: pending
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium
Patient reported cellulitis due flu vaccine received on 11/2/2; she was calling to about the status of her antibiotic and triamcinolone 0.1% cream written on 11/7/23.  The rph asked the patient if she had if she had reported this matter to the pharmacy before, but she said that she hadn't and didn't blame the pharmacy/immunizing RPH for the adverse event because she said that "cellulitis can happen". She said she felt the issue start "immediately, right away after getting the vaccine" but did not say anything to the pharmacy staff at the time.
pt to hosp d/t severity of sx anxiety & agitation, heart palpitations, joint pain;
I had my first dose in March of 2019 and second dose in May 2019 as directed by information provided. Yesterday, September 14th, I broke out in Shingles. This vacination which I paid out of pocket, did not prevent the Shingles from reoccuring.
pt recv vax; one wk later, exp fever to 105; v,d; adm to hosp 7jul95 w/ dx of lt lower lobe pneumonia; pt remains hosp at this time & is receiving IV atb therapy;
Vasovagal Syncope Pt did say she had not eaten anything  but a cookie and some sunflower seeds for breakfast and nothing for lunch.
Pain in injection site (severe), sore muscles, fatigue, chills, could not move legs, muscle weakness, right arm so sore could not move for 24 hours
RECEIVED vaccine 5/18/21; 5/20/21 evening, large red, swollen area with moderate tenderness to injection site - arm was one inch bigger in diameter than non vaccinated arm - lasted close to a week; 5/23/21 afternoon, noted moderate swelling on lymph node under ear lobe behind jaw, tenderness to palpation, fatigue, any chewing on that side of mouth was unbearable as sharp shooting pains in the swollen area resulted; was unable to close jaw fully due to pain during this time;  remained on soft food and liquids only through 5/27/21. Lymph swelling subsided this day, while tenderness continued through 5/30/21.
The patient felt very ill about 4 hours after receiving the vaccination. He felt nauseous, had flu-like symptoms, fever, diarrhea, body, aches. The patient took Aspirin on that night to relief his fever. He called us the next day, and the pharmacist talked with him and counseled him. He is doing better but does not intent to take the second dose that is due in 2-6 months.
This spontaneous report as received from a physician refers to an unknown number of patients. Case 5 of 6 of the same reporter (related cases 1211USA005695, 1211USA005837, 1211USA005838, 1211USA005839 and 1211USA005841). The patient was vaccinated with GARDASIL in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse was reported. Additional information has been requested.
Pt with temp up to 102, swelling of leg to below knee - red, warm to touch, painful. Instructed to continue use of Tylenol/Motrin and ice pack to help with discomfort. Give pt Benadryl or Atarax every 6 hours, call in AM with report on how pt is.
Injection site on left arm hard red swollen. Heart has been fast & having frequent palpitations/ uneven rhythm
Patient received 1st dose of Hepatitis B on 2/9/07 at 1430.  On 2/9/07 at 1715, patient presented to ER with complaints of dizziness, slurred speech, and tight throat.  ER doctor gave Benadryl 25 mg PO X 1, Zantac 150 mg PO X 1, and Decadron 8 mg IM X 1.  Patient was released home with instructions to continue taking Zantac and Benadryl PO
Woken from sleep approx 11hrs after shot. Chills, mild fever, uncomfortable, joint pain including wrists and fingers, lymphnode in left armpit sore. As time went on alternated between chills and sweats. Symptoms continued for approx 36hrs. Lympnode soreness lasted approx 3days
Information has been received from a physician concerning a 20 year old female with allergy to unspecified medications who in approximately December 2006, around 2 months ago, was vaccinated with the first dose of HPV (lot #not reported). Concomitant medications were unspecified. In approximately December 2006, five minutes after receiving the first dose of the vaccine, the patient experienced tingling around her mouth and numbness that lasted for 20 minutes. The patient sought medical attention. The patient was then sent home and had no further problems. The patient did not continue the vaccination series because of the reaction. At the time of reporting, the patient had recovered. No further information was available at the time of reporting. Additional information has been requested.
Patient received 2nd dose of Pfizer 14 days after first dose (too soon).
left arm was sore, red and swollen in a circular pattern around the injection site; left arm was sore, red and swollen in a circular pattern around the injection site; left arm was sore, red and swollen in a circular pattern around the injection site; sliced fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (sliced fever), HEADACHE (headache), INJECTION SITE SWELLING (left arm was sore, red and swollen in a circular pattern around the injection site), INJECTION SITE ERYTHEMA (left arm was sore, red and swollen in a circular pattern around the injection site) and INJECTION SITE PAIN (left arm was sore, red and swollen in a circular pattern around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (Since year 2000, no recent changes in status of condition) and Allergy to intravenous contrast media (IVF dye). Concomitant products included ROSUVASTATIN for Cholesterol high, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for Prophylaxis.   On 15-Jan-2021 at 7:24 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 7:24 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (sliced fever) and HEADACHE (headache). On 13-Feb-2021, the patient experienced INJECTION SITE SWELLING (left arm was sore, red and swollen in a circular pattern around the injection site), INJECTION SITE ERYTHEMA (left arm was sore, red and swollen in a circular pattern around the injection site) and INJECTION SITE PAIN (left arm was sore, red and swollen in a circular pattern around the injection site). The patient was treated with PARACETAMOL (TYLENOL) 12-Feb-2021 for Headache, at an unspecified dose and frequency. On 12-Feb-2021, HEADACHE (headache) had resolved. On 15-Feb-2021, INJECTION SITE SWELLING (left arm was sore, red and swollen in a circular pattern around the injection site), INJECTION SITE ERYTHEMA (left arm was sore, red and swollen in a circular pattern around the injection site) and INJECTION SITE PAIN (left arm was sore, red and swollen in a circular pattern around the injection site) had resolved. At the time of the report, PYREXIA (sliced fever) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Significant Follow up- information including patient demographics details, Concurrent conditions, Concomitant medications added, and additional events. On 07-Jul-2021: No new information was provided.
Pt developped extreme pain, soreness and swelling size of tennis ball. Pt will go to urgent care center immediately to be assessed by physician.