chrisvoncsefalvay/vaers-outcomes huggingface dataset:
22 hours after injection; extreme weakness. Inability to stand, walk, rise from chair.  Fell to floor of home, lay there. Wife called 911. In ER: some fever and high B.P. discovered. IV. Chest x-ray. After 2-3 hours felt improved. Discharged after about 5 hours. Diagnosis: "Vaccine reaction. Fatigue." Slept normally. Feel well, normal now (10:00 a.m. 2/12/21)
Pain, erythema, tenderness 24 to 48 hours after injection. In 7-9 days, fever, erythema, pain, tenderness mid mid and 4 areas of 4-5cm diameter.
Pt quickly became dizzy and lightheaded after receiving vaccine. Pt has history of fainting after giving blood and recognized symptoms and progression/resolution of symptoms were similar to prior experiences. Pt was pale and experiencing cold sweats for a few minutes. Pt stated he was dehydrated and has anxiety with getting shots. Pt was given cool rag, assisted to floor, observed until feeling better. BP was 115/71 HR 62
Rash - urticaria scalp + flank 5 days after vaccine (2nd). Still persisting after 5 weeks.
Patient received vaccinations on 3/11/13. In the next 24 hours she developed increased fever associated with an episode of seizures (x 2) that lasted > 15 min. Patient recovered completely (Hospitalized x 2 days).
Td administered 8/21/02. Pt called 8/23/02 stating on 8/23/02 2pm "felt difficult". ppm neck felt tight and painful HA began pressure around behind eyes. Loss of appetite by dinner time and ate only cereal post nl lunch. 10pm temp 101.9 F. 8/23/02 temp 9:30pm 97.9 degrees still ill. Seen for FU 8/23/02. Injection site ~10.-1.5cm edema/erythema punction site from needles. Off work 8/22/02 until reevaluation 8/26/02. 8/26/02 improved, not resolved. RTW 8/27/02.
A pharmacist reported that a pt received Prevnar and subsequently developed swelling at the injection site. The pt was taken to ER. No further information was available at the date of this report.
Started out as red bump/rash on arm. The next day it had grown and looked more like huge mosquito bites. Grew for a few days. It was warm to touch and itchy. At times it felt like a sunburn. Used over the counter itch medication. Tried Benadryl the second night. Finally reduced but can still tell where some of the rash appeared (maybe because of how pale I am?). Didn't have any kind of reaction like this the first two doses.
Second dose administered too early (21 days); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered too early (21 days)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered too early (21 days)). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered too early (21 days)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.
Suspected vaccination failure; herpes zoster rash in right eye/eye herpes zoster; herpes zoster rash/herpes zoster rash on forehead; herpes zoster rash/herpes zoster rash on forehead; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 70-year-old patient who received Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   On 11th December 2018, the patient received the 1st dose of Shingrix. On 14th February 2019, the patient received the 2nd dose of Shingrix. On 17th June 2019, 188 days after receiving Shingrix and 123 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster and rash zosteriform. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, herpes zoster and rash zosteriform were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster and rash zosteriform to be related to Shingrix and Shingrix.  Additional details were received as follows: This case was reported by the office manager. On 18th June 2019, the patient presented with 1 day duration of herpes zoster rash on forehead and right eye. Appropriate treatment was started and the patient was referred to opthalmologist.  On the day of reporting, the herpes zoster rash was more involved on the forehead and right eye.  The patient was started on appropriate treatment.  It was unknown, if these events were related to the Shingrix vaccine. The reporter agreed to follow up from Glaxosmithkline (GSK).
I was congested and had a low-grade fever. I was fatigue and felt as if I had a very bad cold. After 3 days I tested negative and another 4 days went by and I tested positive again.
Deep ache in left arm along with heat, progressed to severe pain, loss of feeling in hand, extreme swelling and loss of range of motion.  Loss of range of motion continued to current frozen shoulder.
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 02/01/2023.
Low grade fever for 48 hrs, fine maculopapular rash developed 2 days after vaccines; no treatment necessary.
Progress Notes MD (Physician) ? ? Endocrinology    COVID VACCINE CLINIC 12/22/2020    Patient: Date:  12/22/2020                                                                                           Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    Afebrile 98.6   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with wheezing and dyspnea, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse.   Vitals were normal Checked her blood sugars-normal at 108  Offered her snack/water-she declined.   Repeat BP normal at 112/72     Vitals:   12/22/20 1737 BP: 126/82 Pulse: 87 SpO2: 100%          Objective     Physical Exam Vitals signs reviewed.  Constitutional:      Appearance: Normal appearance. She is normal weight.  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat. Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.           MD Electronically Signed 12/22/2020 5:38 PM
6/1/2023 10:25: from mother, to inform of client developing allergic reaction after receipt of vaccines yesterday. Of note client received first dose of VAQTA Hepatitis A vaccine. Mother states at appx. 1630 client developed hives that started at head and spread to trunk and extremities (while at home). Facial swelling, cough and wheezing developed. Mom states she administered Loratadine PO and drove client to ER. Client was given steroids and Benadryl at ER where s/s improved. After monitor until appx 2200 client was sent home w/ script for oral steroids. Mother states she has also been giving Benadryl q 6 hours per ER physician instruction. Client f/u w/ by Dr, PCP this am.  Mother states client's s/s have continued to improve since yesterday afternoon. Mother states physician informed her allergic reaction was likely d/t receipt of Hepatitis A vaccine as no new foods, detergents, soaps, etc. had been introduced. Mother was instructed by PCP to not complete client's Hepatitis A series. This nurse discussed contraindications and description of VAQTA vaccination including neomycin component. Informed mom this nurse to submit report and update allergy list. Mother verbalized understanding and without further questions at this time.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (unknown demographics) who received an expired dose of vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies received. On 10-Oct-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot PNCU1852AD (expiry date: 30-Jun-2018). It was a case of actual medication error due to expired vaccine used. No AE symptoms noted. 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 in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
CVA (cerebral vascular accident). ED Visit and hospital admission. This visit was within 6 weeks of receiving vaccine.
Approximately 2 minute after COVID-19 vaccination, the patient felt tingling and swelling of the tongue, followed by difficulty swallowing. Patient face and forehead was red and flushed about 15 minutes after vaccination. Some tightness and chest after the tongue swelling. Patient also felt some tightness of throat. About 40 minutes after vaccination patient received 25mg Benadryl and 40mg Pepcid. Patient feeling better 5-10 minutes after Benadryl/Pepcid. Tightness in throat much approved. No vomiting, diarrhea, fever. All symptoms resolved and patient discharge to home.
mom reported T102 x 3hr;child began to scream, loose stools & cramping;finally mom called back on 6/28 exam normal;no sx p/that;pt was still crying;8/30 for exam doing well;
Before my vaccination I was experiencing a pain in my arm. My left arm. I received my shot in that arm also. The pain felt like sharp and throbbing, and after getting that injection it has worsen. The pain went from about a five to a eight. I was trying to decide to have in that arm since it was already hurting. On 12/2022 I had a doctor's visit, I was referred to physical therapy and already had two visits as of today. My condition has improved tremendously.
Narrative:  Patient reported significant reactions to COVID vaccines. After 1st dose, felt ill and spent three days in bed. Primary symptoms of nausea, extreme weakness ("unable to walk very far"). Alternated between sweating profusely and then chills. Also reported anorexia, no taste, diarrhea, intermittent lightheadedness, palpitations. After 2nd dose, bedridden for 7 days. Same symptoms reported but worse per patient. Unable to sleep well due to sweating and chills. O2 86% on room air at times (per PCP note). He did review new shortness of breath with exertion several days after 2nd COVID vaccine dose (given 3/16, reported 3/25)** He was not tested for COVID during this time.**Testing was considered by treatment team but patient declined if nothing would be done other than symptoms management.
Severe nausea.   101.2 temp. Severe stomach pains. Chest pain. Severe diarrhea. Numbness in finger tips. Unsteady on your feet, loss of balance. Blurred vision first 2 days.
Light-headed, fading vision, caused fainting post vaccine. Patient fell to the floor and had come back within seconds. Patient was evaluated in place for 1 minute and recovered. Patient was escourted to a chair and talked with a watcher for 15 minutes.
Patient has a history of drug sensitivity to oral penicillin with a rash that developed greater than 4 hours after ingestion.  The patient was administered Moderna vaccine Lot 016M20A at 1025 to the right deltoid muscle.  At 10:49 the patient complained of facial itching, also stating a headache within minutes of injection.  Patient was assessed, BP was 186/92 and HR 72. the patient was alert and oriented without signs of immediate distress.  Just prior to administration of epi the patient complained of chest tightness. Patient BP was noted to be 182/94 at 5 minutes post epi. Ambulance arrived 11:05am and the patient was released to the care of EMS.
2nd set, mother reported to physician that child was crying inconsolably after injections and was irritable and different for 7-10 days after. Her LOC was slightly drowsy all the time. She was eating and arousable but not the same. Dr will hold next pertussis injection. No problems w/ 1st set of immunizations.
Within 11 hours of the Moderna booster vaccination, my left arm pit began to swell. The most swollen my arm pit (lymph nodes) was was the size of a small avocado. It was very painful to touch my arm pit or try to relax my arm. The swelling was so large I believe it was pushing on a nerve and my entire left arm was numb and tingly. My body including my joints were achy for the first 24 hours.
1.3 ml diluent mixed in a 6 month-4 year old vial. Should have been 2.2 ml of diluent. Parent was contacted by Dr. to report error later on the same day.
Information has been received from a physician concerning a 14 year old female who on 10-AUG-2007 was vaccinated with the 1st dose of GARDASIL. The doctor stated that the patient has not experienced a period time the time of that vaccination. The patient was vaccinated with the 2nd dose of GARDASIL on 12-Oct-2007. The patient received unspecified medical attention and at the time of this report, the patient has not experienced a period. Additional information has been requested.
swelling; This is a spontaneous report from a contactable consumer(patient).  A 79-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 intramuscular on 18Feb2021 10:00 (At the age of 79-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER BION-TECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 intra-muscular on 27Jan2021 15:30(At the age of 79-year-old) as dose 1, single for COVID-19 immunization. The patient experienced swelling on an unspecified date in 2021. It was reported that prior vaccinations and relevant tests was None. The AEs required visit to Physician office. Therapeutic measures were taken as a result of swelling with ACE inhibitor. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient is a 54-year-old male who was admitted to Hospital in acute decompensated heart failure on 26Oct2021, after developing rapidly progressive shortness or breath and diffuse anisarca following receiving his second COVID-19 vaccination on 18Oct2021.  Cardiac magnetic resonance imaging revealed late gadolinium enhancement consistent with myocarditis. He was diuresed with intravenous furosemide and started on guideline directed medical therapy for heart failure with a reduced ejection fraction.
Pt vaccinated with MMR & experienced acute pain in rt hand & fingers w/stiffness dx as acute tendino arthritis & prescribed Prednisone covered by Ampicillin. See WORM for more details.
Nerve pain two weeks after her first dose; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th February 2021, 14 days after receiving Shingrix, the patient experienced nerve pain. The patient was treated with gabapentin. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself. The patient received 1st dose of Shingrix and experienced nerve pain. The patient was not sure whether the nerve pain was vaccine related or not.  The patient indicated that her symptoms slightly improved after her physician prescribed Gabapentin for her ongoing nerve pain condition. The patient was not able to provide Shingrix vaccine lot number and expiration date. The patient was able to provide her own email address but not her physician's email address. Hence, could not collect the patient's date of birth. The reporter consented to follow up.
Developed urticaria 2 1/2 hrs after receiving vaccines in the office: KINRIX and Flu shot.
Pt recv vax on 1/13/99; on 1/14/99 pt exp fever (-104.3) & congestion; dx=acute otitis media; tx=Augmentin
Headache, fever to 103, body aches, and fatigue. Treated with fluids and rest
Administration Error: Syringe needle loose. Small amount of vaccine leakage during injection. Doctor notified. No additional vaccine given.
Tingling in left arm around vaccination site Narrative:  1140hrs: BP=160/90 HR 70 O2=97% 1155hrs: BP=149/89 P=70 O2=96% 1215hrs: BP=156/95 P=95 O2+97% ice pack applied to injection site/ juice/ water given
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (Strength, anatomical location and route) of lot # M020071 with an expiry date of 18-JUL-2017 (Expired product administered), at a dose of 0.65 ml, once for prophylaxis. Co-suspect therapy included sterile diluent of lot # L034399 with an expiry date of 16-APR-2018. No adverse effects were reported. There was no product quality complaint involved. Lot number, M020071 has been verified to be a valid lot number for ZOSTAVAX.
Patient received flu vaccine on 12/29/2005 and began to run low grade temp and broke out in rash on 12/30/2005.  Rash was located on trunk and arms.   No history of egg allergy. (1/4/2006)The rash if fine, macular, slightly raised, no vesicles, warm to touch. More on arms and legs last weekend and now mainly on back (1/4/2006). Calamine lotion and benadryl recommended.
pt did not have any adverse reaction however pt mistakenly received a 3rd shingrix vaccination which was unneccesary
On  8th day after vaccine on Saturday 2/20, I started to experience "covid vaccine arm" - a very large (2 inches by 3 inches) red patch on my left arm below the injection site.  The rash was hot, hard and very itchy.  It was slightly itchy the days leading up to Saturday.  I also experienced minor muscle aches that came and went.  I iced my arm and applied hydrocortisone cream and later Benadryl cream.   In the later evening, around midnight, my face also broke out in a red and hot rash.  It did not itch.  My eyes felt a bit tight.  The rash was mostly on my cheeks. I applied some Benadryl cream to my face as well.  I also took 25 mg of Benadryl.  The symptom eased within an hour.  When I woke on, the rash on my face was hardly visible.  The rash on my arm is still visible, but is no longer itchy, hot or hard. I have not had to take additional Benadryl.  I plan to call my doctor and allergist on Monday.
administering the ActHIB twice to the patient that received the correct diluent; received the incorrect diluent; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA172523.  This case involves a 6 months old female patient received the incorrect diluent of third dose of HIB (PRP/T) VACCINE [ACT-HIB] on 21-Jun-2019 intramuscularly in right thigh (LOT: UI973AA, exp: 04-April-2020,)and administering the ACTHIB twice as first dose an second dose both intramuscularly in right thigh on 31-Jan-2019  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 Immunisation; pneumococcal vaccine conj 7v (crm197) (Prevnar) for Immunisation; and rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation.  It was an actual medication error due to Wrong solution used in drug reconstitution and overdose.  It was unknown whether patient experienced any adverse reaction after the injection.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.; Sender's Comments: It is not possible to state which of these entered medication error scenarios belong to each of these patients. A physician reporting having 2-patients received the ActHIB injection on the same day and one received the correct diluent and one-patient that received the incorrect diluent. The physician does not know which patient was given the correct or incorrect diluent. The physician only reported that the staff uses diluents that are stocked separately in the clinic with the ActHIB and as per the inventory, the wrong number of diluents are missing if a dose was to have been given correctly.
Rash at injection site and chest area.  30mg Benadryl given rt deltoid IM observed for 30 minutes. Doing well before leaving no additional issues