chrisvoncsefalvay/vaers-outcomes huggingface dataset:
under my arm on the lymph node are swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was Unknown), via an unspecified route of administration on 05Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced under my arm on the lymph node are swollen. The patient stated that "I had a Pfizer shot on Thursday and under my arm on the lymph node were swollen and I know was that was it was normal for do that and how long its takes for that swelling to go away or do I need to have it checked". Reporter seriousness for under my arm on the lymph node are swollen was unspecified. The patient stated will just call regular physician. The case is not related to a study or programme. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site started itching; pain at the injection site; swelling at the injection site; fever; sleepiness; pain in the right arm / used my arm for 4 hours and after it was hurting / arm is still sore; joint pain in my right shoulder; knot on her armpit, like a swollen gland; knot on her armpit very painful; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included drug used in diabetes (Diabetes Medication (Nos)).   On 21st August 2021 16:30, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, fever, sleepiness, pain in arm, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain. On 21st August 2021, the patient experienced injection site pain. On 25th August 2021, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, sleepiness, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain were unknown and the outcome of the injection site itching and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching, fever, sleepiness, pain in arm, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. Patient reported that she had diabetes mellitus type 2 and was on medications (unspecified) for this condition.  The patient received first dose of Shingrix vaccine in right arm at a local pharmacy and immediately experienced pain at the injection site. The patient experienced swelling at the injection site, fever, sleepiness, pain in the right arm and joint pain in right shoulder. The patient reported that she had a knot on her armpit, like a swollen gland and it was very painful. The patient reported that she ate right and exercises daily.  On the day of reporting, 4 days after receiving vaccination, the injection site started itching and arm was still sore.  The patient reported that at her part time job she used her arm for 4 hours and after it was hurting.  The patient provided consent to follow up with healthcare professional. The reporter consented to follow up.
Left side tonic/clonic seizure within 12 hrs of imm's given, afebrile. Admitted for observations overnight.  10/19/07 Reviewed hospital medical records which reveal patient experienced grunting, irritable, reduced oral intake in afternoon after vax.  Went to ER & d/c to home.  Later same day tegan twitching w/rapid eye movement & then tonic clonic jerking of left side.  Returned to ER via EMS.  Valium in ER aborted seizure. Afebrile.   Very sleepy & lethargic after seizure.  Then vomited.  Admitted 9/12-9/13/2007 for observation.  Neurology consult done.  D/c to home w/neuro & pcp f/u. FINAL DX: tonic clonic seizure. 10/19/07 Reviewed pcp medical record & vax record which reveal patient in excellent health on 9/12/07.  RO dose & Lot # confirmed as correct.
one week after I received the vaccine, I woke up with a swollen and itchy upper arm (same as the injection site).  It took 4 days to resolve.
After receiving the vaccine I had a little bit of tiredness and soreness at the injection site. In January 2022 I had developed a sinus infection. I was put on a Z-Pak antibiotic. The sinus infection went away, but the headaches didn't go away. The headaches started to get worse. I was referred to see a neurologist. He put me on prednisone. It helped but when I stopped taking that medication the headaches came back. Then he put me on amitriptyline 10mg for 30 days. The headaches didn't go away completely, but they were a lot less. The headaches are not as bad anymore, and they are more manageable now.
Patient is a 84 y.o. male who presents today with cough and shortness of breath.  Patient has history of dementia and is a poor historian.  He is uncertain why is in the hospital at this time.  I spoke to his wife over the phone who states patient has been sick for approximately 2 weeks.  Initially, they thought they had a typical cold as they have both been vaccinated against COVID.  However, when cough did not improve and shortness of breath worsened wife was tested for COVID and found to be positive.  Son also tested positive for COVID.  Patient had outpatient testing on 10/25/2021 and found to be positive for COVID.  He came to the ER tonight as he was having worsened dyspnea and noted hypoxia at home.  Wife states his appetite has been fine.  There has been no vomiting but he admits to diarrhea.  He is chronically incontinent of urine.  He has recurrent falls with gait instability.  Wife is struggling to care for him at home as she is fatigued from her illness.  Despite symptoms, patient drove himself to cardiac rehab last week.ASSESSMENT / PLAN: * Acute respiratory failure due to COVID-19  Assessment & Plan Per wife, patient has been ill with cough for at least 2 weeks.  Wife and son recently tested positive for COVID Patient was vaccinated 02/2021 Tested positive for COVID 10/25 Hypoxic down to 88% requiring 2 L of oxygen Outside the window for remdesivir.  Also poor candidate given LFTs Treat with Decadron 6 mg daily Wean oxygen as able Symptomatic treatment with albuterol and Tessalon     Chronic diastolic heart failure Assessment & Plan No evidence of acute exacerbation at this time.  BNP is slightly elevated but no pulmonary vascular congestion on chest x-ray Continue home Lasix Monitor I/O closely.  Keep dry with covid   COPD (chronic obstructive pulmonary disease)  Assessment & Plan No active wheeze on exam Continue albuterol p.r.n. Currently on Decadron   Lewy body dementia  Assessment & Plan Is able to live at home with wife.  Continues to drive Poor historian Continue home medications Wife is unable to visit as she has COVID, however she should be contacted for medical decisions   Status post implantation of artificial urinary sphincter Assessment & Plan Wife states he is chronically incontinent of urine   HTN, goal below 130/80 Assessment & Plan Continue Norvasc and metoprolol in addition to Lasix     Paroxysmal atrial fibrillation  Assessment & Plan Continue amiodarone and metoprolol No anticoagulation due to history of hematuria Monitor on telemetry
Got PREVNAR 13 on Monday 10/31/16 at 11:51 am: when woke up Tuesday had reaction size of a quarter. Started spreading and felt warm and itchy Wednesday. Pt took 2 BENADRYL. At 9pm Wed, 3AM 11/3 and 9 am 11/3. Went to ER-was seen at 10 am 11/3. MD said it is not cellulitis. MD states "other local reaction vs cellulitis." (Primary care doctor was not open or they would have gone to Dr).
Case number PHEH2013US18580, is an initial spontaneous report received from a medical assistant on 30 AUG 2013, with a follow-up received on 30 AUG 2013. This case refers to an 11 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number M12124, expiry date: AUG 2014), reconstituted with diluent from Merck, intramuscularly on 30 AUG 2013. No adverse reaction was reported following this administration error. Medical assistant inquired whether the patient should revaccinate. Follow-up was received on 30 AUG 2013. Expiry date of vaccine was updated.
Moderate to severe injection site pain; Injection site stiffness; muscle aches; chills; a general unwell feeling; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 31Mar2021 at 11:15, (at the age of 42-years old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 01Apr2021, at 00:00, the patient experienced moderate to severe injection site pain and stiffness, muscle aches, chills, and a general unwell feeling. The patient woke up at 6:30, on 01Apr2021 feeling stiff and sore, but much better. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe injection site pain, chills, a general unwell feeling, stiffness and muscle aches was recovered on 01Apr2021.   No follow-up attempts are needed. No further information is expected.
Redness, swelling, itching, and warmth to the injection site. Rash has spread over the course of a few days and has become larger each day (3 days). We were asked to monitor the spot and any other symptoms. Treating with cold compresses and Hydrocortisone. If it continues to spread, antibiotics may be used to treat incase of infection.
Pt is explaining excruciating pain in left arm, numbness and tingling all the way down to his fingers. He explains that he has pain in underarm and potential swollen lymph nodes.
received Tubersol injection by accident instead of the ordered influenza vaccine / no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA296269.  This case involves Adult male patient who received vaccine TUBERCULIN TEST [TUBERSOL] instead of INFLUENZA VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong product administered.  It was reported that received Tubersol injection by accident instead of the ordered influenza vaccine.  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.  Information on the batch number was requested.
I had a dry cough on Monday, at night I started not feeling well. Tuesday morning I had a sore throat and general fatigue. I tested myself for COVID-19 and was positive. I went to Urgent care and got the antigen test and was negative. They gave me Paxlovid and I took it for the next 5 days. I quarantined and after 3 days I felt better. After 5 days days I went back to work wearing a mask for 6 days. The general symptom was fatigued.
lack of tasting hot spice food; have a Tingling right hand slight but noticeable.; 101.9 fever; headache; severe sore body aches for 35 hrs; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el 9266, patient was 55-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 16Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure, blood pressure, diabetes, mitral valve prolapse. Concomitant medication(s) included atenolol (ATENOLOL); metformin (METFORMIN); triamterene (TRIAMTERENE); lisinopril (LISINOPRIL); glimepiride (GLIMEPIRIDE) all taken for an unspecified indication, start and stop date were not reported in 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: en5318), via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 09:45 as DOSE 1, SINGLE for covid-19 immunisation. No COVID prior vaccination, no COVID tested post vaccination. No known allergies. No other vaccine received in four weeks. Reported that patient had indian food spice level 3 very hot couldn't taste it but can smell and taste most everything else. On 16Feb2021 at 20:00, the patient experienced 101.9 fever, headache, severe sore body aches for 35 hrs, on 19Feb2021, the patient experienced lack of tasting hot spice food, have a tingling right hand slight but noticeable. No treatment for AE received. The patient underwent lab tests and procedures which included Fever resulted as 101.9 fever. The outcomes of events were not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Breakthrough case admission after 3 vaccines Moderna 2/6/21 lot# 031L20A;  Moderna 3/6/21 lot# 030A21A;  Moderna 11/2/21 lot# 071F21A
The patient received influenza vaccine on 9/29/10 at approx 3:00 pm. Post vaccine the patient started breathing rapidly, trembling, & fainted. No medicine was given to her all. We elevated her legs and patted her head & neck with damp paper towels. 911/EMS was called.
3 inch diameter local reaction consisting of raised redness and tenderness. Facial hives with itching. No breathing difficulty.
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 14Apr2021 at 19:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to paint vapors and perfumes. The patient was not diagnosed with COVID-19 prior to immunization. Concomitant medications were none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER2613) on 24Mar2021 (at the age of 38-years-old) in the right deltoid for COVID-19 immunisation. On 15Apr2021, following administration of the second vaccine dose, the patient experienced tinnitus. It affected both ears but was more noticeable in the left ear where the frequency had gone from a static-like buzz to a high-pitched continuous beep. This event resulted in a physician office visit and was reported with a seriousness of disability or permanent damage. The patient was not treated for the event. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of "tinnitus (affects both ears, but it is more noticeable on the left)" was not resolved.
Dull chronic stomach pain (center upper abdomen to left upper abdomen) that is aggravated by eating and drinking including swallowing saliva. Has been going on since 11 pm of date of vaccine (2-3 days).  I tried ibuprofen on the first day but it did not help.
Pt went to bed at 2 AM, woke up at 4 AM, SOB, felt like tongue was swollen, heart rate increased, felt panicky, hyperventilating, looked for bag to breathe into. Watched TV until calm; episode occurred over about 30 mins
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
10.23/2001 Headache, sore arms, severe chills although afebrile. 10/24/2001 Vomiting 7-8 times by 4pm referred to ER.
The same day post vax, the pt experienced a burning sensation, dizziness, and was sweaty, shaky, and saw spots. Blood pressure was nml. He was taken to the ER. He was recovered and as of 03/16/2000 is doing well with no complications noted.
Back/Flank pain, nausea, vomiting, and dark urine. Started on 5/17/2021 at around 1am and ended up going to the Emergency room for evaluation and was found to have 2 kidney stones - 1 in the right kidney and 1 in the distal right ureter. Had to have cystoscopy with stone removal from distal ureter complete as outpatient procedure on 05/21/21.
Rapid onset of localized swelling of about 1.5cm and mild redness. Warm and tender to the touch. Within 5 minutes began to have tingling of the arm. Was given Benadryl 25mg PO with good effect.
Diagnosed with shingles on March 15th - approx. 72 hours after receiving vaccination.  Note that I had developed a minor rash that one week BEFORE receiving the vaccination, but that shingles rash became much worse in terms of pain, intensity and spreading after receiving vaccine.
extremely itchy lichenoid; got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000067 (RA).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "extremely itchy lichenoid"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "extremely itchy lichenoid". The following information was reported: LICHENOID KERATOSIS (medically significant), outcome "recovering", described as "extremely itchy lichenoid"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "got worse".  Clinical course: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunisation. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
pt said she had a rash that developed under her breasts an hour after receiving the vaccine. pt took Benadryl and went to sleep. Rash was there still when she woke up and she also had flu-like symptoms
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 21-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Reddish, hard bump at location of both injection sites. Not painful but feels like small bee-bee in arm at both sites. Neither have changed shape, size or color since being discovered after second vaccine dose.
C/O SA/nausea. Pale, quiet-sweaty brow-had juice/gold fish, said feels hot, T 95.7, pulse 80-Rest in health office-9:45 TC to mom-she talked with son-encouraged try recess-Reassessed at 11:00, feeling fine.
29yof presented to ED with nausea and shaking which was happened on and off throughout the past day after receiving Tdap vaccination the day before.  Patient was prescribed hydroxyzine 25mg tablet bid prn. Patient described their symptoms to include soreness at injection site, muscle contractions but their body was not doing anything and discoloration to nail beds which were documented to have been blue.  Patient was instructed to follow up with their primary care physician.
ACHEY; MILD CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced achey, and mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild chills, and achey. This report was non-serious.
CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS