chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt with COPD on 3L home O2.  Pt transferred from facility with acute hypoxic respiratory failure secondary to COVID-19 pneumonia.
The patient experienced cramps and diarrhea within the first 24 hours after the vaccination, lasting approximately 48 hours.
Severe, SEVERE flu like symptoms which nearly prompted a trip to the emergency room. I could not change my own clothes my myalgias and joint pain were so severe. I was sobbing in my kitchen and my fiancé had to help me move around the house. I was slowing my speech and mentation. Severe headache. I made my fiancé wake me up every two hours to make sure I wasn?t decompensating.
Tinnitus - loud ringing in both ears. Have apt with hearing specialist this week. Ringing started as mild but has progressed to relatively loud ringing.
pt recvd vax 12MAY92 @ 215PM exp screaming began @ 5PM in MD office; rt leg purple; lt leg purple-bright pink rxn on inject area;
Patient states severe redness, inflammation, extremely painful and warm at the site and around area of injection. Seen by her MD who gave her a steroid cream and BENADRYL. Symptoms resolved after a few days.
my lips were numb; throat was tight; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 12:30 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included gabapentin (GRALISE) 600 mg at bedtime. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021, 30 mins (at 13:00) after vaccination, the patient experienced numbness in lips and throat tightness. The patient had not received any treatment for the event. The adverse event had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lips numb and throat tight was recovered on an unspecified date.  Information about lot/batch number cannot be obtained. No further information is expected.
I developed swelling in my left armpit, and pain in my neck. I also had a fever.
Since the vaccine dose 2, I have been worn out, with very low appetitive.  My PCP has conducted all routine exams such as blood work, Lipid profile, Thryoid, and all other required exams.  Recently went and did Covid 19 both antibodies and regular test and antibodies test was positive and the Covid 19 was negative.  Its been more than 8 plus weeks and I still feel worn out and offlate noticed few mood swings.
Initial unsolicited report received from a non-healthcare professional on 31 October 2016. This case involves a 47-year-old female patient who was vaccinated with a dose of Fluzone QIV (Batch number: UI708AB, expiry date: 30 June 2017, dose and dose in series were not reported) intramuscularly in the left deltoid on 24 October 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known drug allergies (NKDA). Illness at the time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 25 October 2016, one day following the vaccination, the patient had developed a fever of 101.5 degree Fahrenheit, shaking, chills and teeth chattering. Other Laboratory investigations were reported as none. Corrective treatment was not reported. The patient was recovered from all the events on an unknown date (reported as symptoms lasted for 24 hours). List of documents held by sender: none.
Rash appeared on left arm below vaccine site approximately 1 1/2 weeks after vaccine with pain and soreness.
Sunday, the redness disappeared but returned yesterday. Redness, the injection site is hot to the touch and has a knot. No fever.
Pt received Janssen dose 0.05ml instead of 0.5ml.  Pt did get re-vaccinated with appropriate dose of Janseen 0,5ml on 9/8/2021.
This case was reported by a physician via a sales representative and described the occurrence of swelling at injection site in a two or three subjects of unspecified age and gender who were vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On unspecified dates prior to 09 August 2007 the subjects received unspecified dose of Infanrix (.5 mL, unknown). At an unspecified time after vaccination physician noted that the Infanrix was "from a particular lot" (lot number not provided), and that another patient had also developed injection site swelling after receiving Infanrix from the same lot (please reference GSK reference number A0670238A). At the time of reporting events were resolved. The physician considered the events were probably related to vaccination with Infanrix.
I woke at 3AM Thursday morning and I had terrible pain in left arm, it down to hand and it was tinging. I took some ibuprofen and the numbness in my hand went away and it did not help with the pain. I got about 4 AM to shower and after my husband got up. I couldn't raise my arm at all and it was hurting bad. I went the ER about 7-8AM on Thursday.  I went to ER and the doctor suspected it to may be a side effect of COVID 19 vaccine. I am doing what they are saying, applying heat and taking Ibuprofen and I am trying to move it. I can lift my arm sometimes I can and sometimes I can't. The pain hasn't improved much. I can't lay on it at night because it hurts so bad. The weird thing is after I got the vaccine it hurt the first day and then it went away until the pain came back on Thursday. Monday and Tuesday before I went to ER my migraines were uncontrollable and my prescription medication was not helping, my migraine usually goes away after I take the medication. The headache was so bad I ended up taking 5 of them each day.   I did not have any side effects with the first dose of the vaccine.
Initial information received from a consumer on 02-Dec-2013. a 67-year-old male patient whose medical history was not reported received and she had intradermally a dose of influenza vaccine (batch number and site of administration not reported). On an unspecified date, after vaccination the patient experienced allergy to vaccine. Lab investigations and treatment medications were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none.
Influenza vaccine listed above was stored in a box labeled prevnar in error.  Office protocol to verify vaccines by 2 staff members was followed.  However, neither staff identified that the syringe was influenza and not prevnar.  Staff then administered the vial 0.5ml IM influenza in error, while intending to administer prevnar.  This was injected into the right thigh at 14:38.  Parent was immediately notified of the error.  No adverse reaction to the influenza vaccine was observed while the patient remained in our office.
Shingles-like rash spread over the arm, torso and on the lower chest; Rash looked like vesicular lesions with no particular dermatome; Look like shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2016US105128).  Information has been received from a consumer referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 dosage form (DF); strength, route, lot # and expiration date were unknown) for immunisation. On an unknown date, the patient was vaccinated with influenza virus vaccine (unspecified) (1 DF; strength, lot # and expiration date were unknown) intramuscularly for immunisation.      On an unknown date, the patient experienced shingles-like rash spread over the arm, torso and on the lower chest, rash looked like vesicular lesions with no particular dermatome and look like shingles. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was not provided. The causality between all events and influenza virus vaccine (unspecified) was assessed as suspected by the reporter.  The events of shingles-like rash spread over the arm, torso and on the lower chest, rash looked like vesicular lesions with no particular dermatome and look like shingles were considered to be medically significant by the reporter.
The indentation is now around the size of a nickel that is dark and has been getting deeper in indentation; The indentation is now around the size of a nickel that is dark and has been getting deeper in indentation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), when the patient was 72 years old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "soreness"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: unknown), administration date: Apr2022, for COVID-19 immunization, reaction(s): "Bruising", "Her skin is dark and it started making like an indentation where it kept sinking where the injection site was", "Skin got brown", "Her skin is dark and it started making like an indentation where it kept sinking where the injection site was". The following information was reported: INJECTION SITE INDENTATION (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "The indentation is now around the size of a nickel that is dark and has been getting deeper in indentation".  Additional information: Reporter stated that they had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart and then got the 3rd, 4th and 5th booster, caller stated they had a total of 5 injections. Caller stated after the 3rd dose, both of them experiences soreness that went away after 3 or 4 days. Caller stated after the 4th dose in the 4th month of this year, about 10-14 days after it made his wife's skin got brown and they thought it was bruising. Reporter stated her skin was dark and it started making like an indentation where it kept sinking where the injection site was. Reporter stated the indentation was then around the size of a nickel that was dark and had been getting deeper in indentation. Reporter stated it had gotten deeper over the last month. Reporter stated when they went to get their 5th injection, the pharmacist said she had never seen that before.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368860 Same reporter and patient, different event;
Fluarix QIV vaccine experienced temperature excursion that occurred for more than 72 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   On 26-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season .5 ml. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: Fluarix QIV vaccine experienced temperature excursion that occurred for more than 72 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2023 The reporter was pharmacist. The reporter reported that that reports Fluarix QIV vaccine experienced temperature excursion that occurred for more than 72 hours. It occurred over several days where temperature fluctuated between 28 to 29 to 55 Fahrenheit. The product received Fluarix QIV vaccine after temperature excursion, which led to incorrect storage of drug. The reporter consent to follow up.
PATIENT SAID HIS ARM WAS SORE FOR A FEW DAYS AND THAT PAIN WENT AWAY.  HOWEVER, NOW WHEN HE LIFTS THE ARM HE HAD THE VACCINE IN, THERE ARE CERTAIN POSITIONS WHEN HE MOVES IT THAT FEEL LIKE A HOT NEEDLE IS BEING STUCK IN HIS ARM, HE SAID IF HE RUBS IT AFTER A WHILE THE PAIN GOES AWAY, BUT KEEPS RECURRING.  HE WILL DISCUSS WITH HIS MD AT UPCOMING OFFICE VISIT
Rash, with pimples and puffy bumps. On hand and wrist (R).
Fever up to 101.7 for 6 hours. Chills, fatigue for 10 hours. L arm pain shoulder to forearm 24 hours. Warmth and ache at injection site 48 hours. Two Tylenol to reduce fever when temperature reached 101.5. Symptoms resolved within 30 hours except warmth and soreness at injection site. Loss of appetite and food aversion has not resolved in the 5 days since the injection.
No side effects from Flu Shot.  Side effects of Shringrix  Shot #1: - Next day - soreness, redness, slight pain - Next day - very sore, redness traveling down arm (from top of arm) to elbow - Pain - had to take Tylenol. - Arm was extremely HOT and BLOOD  RED for 4 days  - Used cold packs on arm. - After 4 days, redness started going away - October 1 - noticed a "peeling" (dry, flakey skin) at top of arm near injection site. - Skin issue still there.  I put lotion on to give it moisture.
Flushing of face, stiffness of neck and arm, pain in arm (left side). Patient took BENADRYL for symptoms of reaction.
Heart racing, heart pounding really forcefully, very high blood pressure (over 240+ at rest) , vertigo , anxiety, shortness of breath, headache, nausea, constant ringing in my ears (still present after 90 days)
1st Vaccine 2/6/21; developed chest pain with SOA on exertion 2/13/21; Seen in ED 2/16/21 for worsening symptoms and admitted to hospital.
Rash on chest, back, abdomen, swollen (blister) mass on back, took BENADRYL and went to ER where they gave her steroids.
Redness, burning, constant itching heaviness in a wide area beyond the injection site. Temperature was a 100.2 for a day and a half. Left side below armpit was tender to the touch for 1 day. I did not have these symptoms with the first 2 shots. This is a complete dose :5 ml, not a booster.   I had the usual fatigue severe body aches and chills. I am continuing to have this burning itch on my arm.
pt recv vax 29MAY97 & later in afternoon pt exp migraine h/a denies dizziness, n/v @ that time;31MAY97 pt beg to exp chills, pt reports sleeping for 3hr p/onset & chills ahd subsided;exp dark urine & diarrhea;no BM since 3JUN97;
Blotchy rash on arms and legs started on morning of February 15.  Went to doctor on Wednesday, February 17.  He gave rx for Hydroxyzine.  Symptom is still existing but not as bad.  Also, had chills the next day after vaccination on Friday, February 12 but only lasted one day and is gone.
HBP reporting AE for improperly stored administered vaccine.   Names of vaccines involved (including lot/exp):  ROTATEQ Lot U037809 Exp 03/26/2023  Temperature (28.0F) BELOW 36°F  Time frame 96 Hours  Previous temperature excursion? No  Additional A; This spontaneous report was received from an office manager (also reported as HBP) and refers to 9-week-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 16-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # U037809 with expiration date 26-MAR-2023 (exact dose was not reported) for prophylaxis. The vaccine underwent a temperature excursion of 28 degrees Fahrenheit (F) for 96 hours on an unknown date before administration (product storage error). There was no previous temperature excursion. The outcome of product storage error was unknown.  On 31-MAY-2022, inbound call received from a healthcare worker. The caller said she received 6 letters from Merck addressed to the office manager, and the office manager no longer worked at the office. The caller wanted to know why those letters were sent. Adverse event process explained to caller. The caller said she would fill out the forms and send back all available information. No further information provided.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA005621: US-009507513-2205USA005673:
I started off having issues with my left jaw, so I did the saltwater gargle and that didn't help long term. I made an appointment because I was having a sinus issue or so I thought. After the appointment I decided to dig deeper. Initially I thought it was a sinus headache, but I was wrong. I did take a home test after finding out my son was positive for COVID-19. I isolated and kept taking the medication I was given to treat what I that was a sinus infection.
About 2 minutes after shots were given; client felt dizzy, weak, light headed. Stated he felt faint. BP dropped, he became diaphoretic. He did not lose consciousness. We gave him a cool cloth for his forehead offered apple juice and had him stay at clinic until symptoms subsided.
Presented with SOB, hypoxia, recent + covid; CXR: Left lung PNA and LLL empyema;  Started on steroids and antibiotics for PNA; 2/21 L VATS for empyema; developed mild ileus post op, recovered by d/c; Meds: Rocephin, Vit c, Vit D3, Zithromax, Decadron, Lovenox, Zinc; Initially on minimal supplemental O2 @ 4 LPM NC; weaned to room air by d/c
Patient called me a few days after I administered the vaccine indicating of difficulty breathing, throat feeling somewhat closed and very tenderness at the sight of injection with a red mark. Patient also indicated to the staff pharmacist on 10/5/16 that she was in the hospital for a few weeks due to the Zostavax interacting with her Prednisone therapy.
This spontaneous report as received from a 72 year old male patient with type 2 diabetes and no drug reactions or allergies consumer reporting on himself. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant therapies included unspecified medications. The consumer reported that on 02-OCT-2014, about a week after he received the vaccination, he experienced muscle pains and joint aches. The consumer reported that he could barely move his arms and legs. The consumer also mentioned he developed a sore throat around the middle of October 2014 that only lasted a couple of days. The patient was suggested to take two ALEVE a day as treatment. The patient underwent a lipid panel and a kidney function test (results not provided). The consumer stated that was still currently experiencing the pain and muscle weakness. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 12 month old patient who was given a dose of (merck) VARIVAX (start date, dosage, route and lot# not reported) in one body site and a dose of (merck) PROQUAD (start date, dosage, route and lot# not reported) during one office visit. No adverse effect reported. Additional information has been requested.
In addition to the anticipated flu-like effects from the second does, I experienced another instance of a large red "rash" around the injection site. Unlike with the first vaccination, the rash appeared after approximately 24 hours and appears to follow the contours of the first rash.
Moderna 0.25 ml IM left deltoid administered as second dose; additional dose Moderna 0.25ml administered IM left deltoid
Information has been received from a physician concerning an 18 year old male who on 29-JUN-1992 was vaccinated in the hospital with a dose of RECOMBIVAX HB (unspecified), on 29-JUL-1992, was vaccinated with a dose of RECOMBIVAX HB (LOT# 603897/0750V) in the right leg and on 22-DEC-1992 was vaccinated with a dose of ENGERIX B in the left leg. Concomitant therapy included ENGERIX-B, ADACEL, ORIMUNE, MMR vaccine, HAVRIX, Hib conj vaccine (unspecified carrier) and MENACTRA. On 19-AUG-2010, sample was collected and the patient did not have immunity to hepatitis b virus vaccine and hepatitis B surface antibody quantitative test was < 5 mIU/mL. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Dizziness a few days after receiving. Also after 2nd vaccine and went to the ER because my dad got scared. The doctor recommended a pacemaker! His pulse was very low. At doctor follow up he was given a heart rate monitor to wear for 2 days
Reason for visit showed, "11 yr WCC" old EMR records were checked and not checked thoroughly showing patient didn't received Tdap nor MCV4. Vaccines administered when I was notified that another record found Tdap and MCV4 were already given the yr before. 11yr vaccines given twice with no adverse reactions noted. Mom notified.
Severe pain in should and arm  along with headache for one day and night.  ibuprofen gave no  help. If  I lifted my arm above  my waste even more pain. Pain gradually went away after 3 days.  A good friend had the exact same symptoms.
fever to 103; vomiting; blanching red papular rash. 2 dozen papules primarily truncal developed 10 days after MMR.
11 yr. vaccines given 6/14/16 at well exam. C/o redness, swelling to vaccine site (left arm) pain to site on 6/24/16. C/o pain to site w/cont. redness, swelling on 6/25/16 and (R) shin pain, (R) wrist pain, and numbness to (R) top on the foot. Seen at hospital ER 6/25/16. F/u here visit 6/27/16. Poss bug bite on top of (R) ft. Poss. puncture site noted on (R) ft.
local react lt deltoid 7PM; redness, swelling 7cm x 11cm over 24 hrs period;
The vial had been initially punctured on 6/29/2021 and was kept in the refrigerator. The vaccine was drawn up on 6/30/2021 and administered.
6/7 positive test at home with an at home rapid antigen COVID 19 test. I had a tele visit with my doctor that day who prescribed monoclonal antibody treatment and PAXLOVID. I had a slight cough.
This spontaneous report was received from a nurse concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L031068, expiration date: 18-AUG-2017 for prophylaxis, which was exposed to 18F for 30.5 hours. It was reported that the vaccine doses did not have previous temperature excursion. No product quality complaint was involved. Additional information is not expected as the reporter did not consent for follow up attempts.
Cough, fatigue, muscle aches, fever of 101.1, headache, sore throat
Severe muscle weakness, blurred vision, was unable to walk up stairs without crawling, loss of balance, severe muscle pain, prolonged muscular pain at site of injection, ; exacerbation of MG symptoms including light sensitivity, eyelid heaviness. Also remarkable decrease with MVV results noted with annual spirometry test requiring 6 week follow up; shortness of breath, poor heat tolerance, scars from prior surgeries are also painful. Increased muscle weakness and general fatigability still noted 2 months post injection.
About 1/2 hr. after shot, turned red felt warm, put ice on it, red spot got bigger about the size of a baseball, got hard, swelled up, red spot is still the size of quarter. It also itched.
Fever to 103.6 with first time seizure.  EMS called and patient taken to the hospital.