chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician regarding an unknown age and gender patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (dose, and route not reported). No other suspect therapies were reported. No concomitant medications were reported. The physician reported that the patient fainted after receiving one dose of GARDASIL (date not reported). The physician reported that the patient recovered and walked out of the office. No treatment information was reported. The reporter did not assess the relationship between faint and GARDASIL. Additional information is not expected.
Itching one day - now better, swelling, heat, mild pain at injection site started 2/3/2021
WOKEN UP BY SEVERE ARM PAIN APPROXIMATELY 12 HOURS AFTER INJECTION.  PAIN DID NOT CHANGE ENTIRE NEXT DAY. SLIGHTLY BETTER SECOND DAY AFTER, HOWEVER I WENT TO WRING OUT A WASHCLOTH IN THE AFTERNOON AND EXPERIENCED EXTREME HORRIBLE PAIN THAT RADIATED IN MY LEFT WRIST.  I HAVE NEVER FELT A PAIN LIKE THAT, I WAS AFRAID SOMETHING WAS REALLY WRONG.  IT SLOWLY SUBSIDED, AND SINCE THEN I HAVE BEEN CAREFUL WITH HOW I USE  MY WRIST AND ARM, BUT IT IS STILL SOMEWHAT PAINFUL AND DOESN'T FEEL RIGHT.  I AM AFRAID I WILL FEEL THAT PAIN AGAIN IF I MOVE/PUSH/LIFT ANYTHING IN A CERTAIN WAY.
pt recv vax; exp fever of 102, hoarseness & sl cough; at time of rpt, sx persisted;
Patient self-scheduled second dose COVID appointment for Pfizer to be administered on 4/14/21. Patient came and was asked in three different locations if she was here for second dose Pfizer, patient states "yes" and showed her vaccine card. Failed to see that card noted that patient received Moderna for first vaccine. Patient went past and was asked two more times if she was here for second dose Pfizer, the patient continued to state that she was. A Nurse administered vaccine, patient had zero complications from vaccine. Patient later looked at card and noticed that she had two different brands of vaccine, patient then proceeded to call into office to report incident. Doctor was immediatly called upon notice of incident. Per Dr., patient does not need repeat dose.
Information has been received from a health professional concerning a 58 year old white female with diabetes, high cholesterol and hypertension who on Oct 05 2004 at 3:: was vaccinated in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). there was no illness at the time of vaccination. Concomitant therapy included glyburide (+) metformin hydrochloride (Glucovance), lisinopril (manufacturer unknown), atorvastatin calcium (Lipitor), pioglitazone HCL (ACTOS) and asprin. On Oct 07 2004 the patient developed a sore arm. The left arm had erythema and swelling proximal to the elbow. There was a small ecchymosis at the deltoid muscle. Unspecified medical attention was sought and the patient was treated with cetirizine hydrochloride (Zyrtec) and acetaminophen (Tylenol). No diagnostic test were performed. Subsequently, the patient recovered. it was reported that the patient may have received the vaccine on Feb 27 2004 but she does not remember if she received it or not. No product quality complaint was involved. No further information is expected.
headache; stood up really fast and got dizzy; light headed; noticed a bruise on her left thigh; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 27Feb2021 15:30 (at age of 45-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had not history and other products. Caller reported that yesterday on 28Feb2021 around 6:30 she was sitting down and stood up really fast and got dizzy and light headed which did not happen often with her. Caller also reported that when she got home she noticed a bruise on her left thigh and stated she have not done anything to bruise herself but she reported that a friend told her that the side effect of getting the vaccine was low platelets and she asked did she have thromcytopia or not. She did not realize that bruising was a side effect of the product. Last night, called noticed a small bruise on her left thigh, the size of a fist. Caller stated that earlier in the day, she had gotten dizzy as well. Caller stated that she was sitting down and stood up too quickly, and she got dizzy, and at first she just thought it was because she got up too quick, but she was a little out of it. Then, caller went away about her day and that evening, when she went to take a shower, she noticed the bruise on her thigh. Caller said that she was talking to a friend who said that the caller needed to go get it checked because unexplained bruising can be a sign of platelet levels going down, because the friend had the same thing. Caller stated that today, she has not been up very long because she works 2nd shift, so it has only been a couple of hours, but she does not feel bad today, and she has no other bruising anywhere else. Caller states that she drank some water, and she not feeling super dizzy or anything, but maybe just has a tad bit of a slight headache on 01Mar2021. But nothing was crazy. Caller was concerned about the bruising though because she does not recall hitting herself or getting hit in that spot. Caller was seeking more information about bruising with the product because she was trying to decide what her next steps should be. The outcome of event headache and noticed a bruise on her left thigh was not resolved while the events light headed and stood up really fast and got dizzy was resolved on 01Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1432hr Pt fell to the ground c/o shortness of breath & dizziness. Dose of J+J vaccine given about 15 minutes prior. B/P 70/50 HR 84 SPO2 100% on R.A., Lungs clear bilateral. Pt complained of tingling in both hands & feet. Pt refused epi but agreed to Benadryl 50MG po Liquid. Benadryl Administered at 1435hrs no improvement, pt feeling more short of breath & Numbness in Lt arm, 1 dose of epi administered at 1440. Pt had no improvement, pt complained of numbness now in right arm. At 1445 a 2nd epi pen was administered. 1447 pt stated he was feeling better. VS taken BP 100/60 R.24 HR 80 SPO2 97% RA. Lungs Clear bilateral. EMS arrived @1448. Pt stable and was transported to the hospital.
With injection No 3 of Rabies vaccine area immediate up rise, red, swollen, evidence of inj No 2 size of a quarter. Up rise and inj No 1 size of a dime. Up rise and swollen. Denies pain. MD evaluated at time up rise; verbal order no more shots.
4:23 PM Pt began to complain of neck stiffness and nausea. She was brought back to exam room and became increasingly lethargic with complaints of chest pressure, numbness in both arms and tongue swelling. She was placed in supine position and 1ml of epinephrine was administered IM in left thigh. She had a visible rash on her left upper arm, chin, neck and ears. One minute after administering Epinephrine the pt reported feeling better.  4:30 PM the redness was improving and the pt was talking 5:00 PM  She began to have shaking in her jaw and left hand and arm. This resolved approximately 10 minutes later without intervention and vital signs remained stable, except heart rate increasing into the low 100's. 5:13 1 ml of Dexamethasone 10mg/ml was given IM in right deltoid. Patient was monitored until 6:15pm and released to return  home.
R arm swollen, feverish red from injection site to wrist.  He had no fiver.  Arm had improved by 9/21/2009
Temp 104 on 3/5/03- N&V-seen at ER.
17 pts (<1yr old) vaxed from a particular lot between 26MAY & 2JUN94 returned to MD office approx 24-48 hrs following vax because of low grade fever, irritability, & inj site rxn of erythema & swelling;tx w/APAP;pt recovered;
did not get enough dose of the vaccine; not administered to her properly because as soon as the syringe from her deltoid, a big gush of blood came out; was not administered to me properly because as soon as she took the needle out, a bunch of blood just ran down my arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was given the vaccine yesterday and she was afraid that it was not administered to her properly because as soon as the syringe from her deltoid, a big gush of blood came out. The patient was thinking she did not get enough dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient missed HPV and Tdap vaccine/ NO AE; Patient received only half of the MENACTRA dosage/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from the consumer or non-healthcare professional via Medical Information (Reference number: 00793014).  This case involves 12-year-old male patient who jump away/ jerked and run off when he was trying to receive a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] about only half the dosage was administered (underdose) and dad was supposed to bring him back but he missed his appointment. He was supposed to get his DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HPV VACCINE but missed those (product dose omission issue).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 21-Sep-2021, the patient received a total dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin skin test, strength: standard, lot number: U7087AA, expiry date: 05-Oct-2022] via an intramuscular route at an right deltoid for prophylactic vaccination.  It was an actual medication error case due to Vaccine underdose and missed dose (latency: same day).  No other vaccines.  It was reported " Office manager states they had a patient jump away and run off while they were trying to administer a dose of MENACTRA to the patient. Caller states about only half the dosage was administered. Caller states he was supposed to get his human papilloma virus (HPV) and combined tetanus, diphtheria and acellular pertussis (Tdap) but missed those".   Caller would like to know if they need to fully revaccinate or if there is another way to move forward.  At the time of reporting, no adverse event was reported.  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. 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.
Fever began 8 hours after inoculation with high of 102.4 S opposed to first dosage of 104.7. Lasted 36 hours Slight chills at onset of fever as opposed to severe shaking and teeth rattling with first dosage. 2 hours Hives on fingers and red rash on injection arm 12 hours after injection   Started as 5? and spread from shoulder to almost elbow. On going with itching controlled by Benadryl  PMR symptoms drastically reduced
Pt. upper arm became very swollen all the way around including part of arm pit, throbbing pain all around and very firm to touch and warm heat, bruised approx 3-4 in in diameter where injection was given.  Took 2 days and warm soars before getting better.   Now only bruised.  No pain.  Also had loose stools for 2 days.
Fever, all over body aches for 2-3 days after injection. Injection site hot, tender for 1 week after
"got sick" after receiving a dose of the vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as ""got sick" after receiving a dose of the vaccine.".  Additional information: Caller is a consumer who wants to know the ingredients of the Pfizer BioNTech COVID 19 Vaccine and why this vaccine make people "sick and hurt". She also mentioned that her male cousin who is around 70y/o (caller wasn't sure of the exact age) "got sick" after receiving a dose of the vaccine. Caller stated that she has not received, and is not planning to receive, a dose of the Pfizer BioNTech COVID 19 Vaccine because she is only in her 30s and do not want to fall ill. It was reported that "During the clinical study some people did not have any side effects, but the vaccine was 95 percent effective in prevention of COVID-19 disease after receiving 2 doses. If a vaccine does not cause any side effects, to our knowledge, this is not related to the dose being less effective than what would be expected in a patient who did have side effects."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received one dose of adult Pfizer bivalent instead of the first dose of pediatric pfizer vaccine. No symptoms were reported.
Two weeks later had Mild persistent Right arm pain and shoulder pain that grew worse to severe pain followed by loss of movement.
This spontaneous report as received from an office manager (healthcare worker) refers to a 12 year old male patient with allergic to KEFLIX and no pertinent medical history. On 05-AUG-2009 the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. On 27-MAR-2013 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot # H010649, EXP date 20-FEB-2015) intramuscularly. There was no concomitant therapy. On 05-AUG-2009 the patient experienced fainted after administration of his first dose of GARDASIL. The patient recovered without requiring medical treatment on an unspecified day. On later of 27-MAR-2013 the patient felt tingling in his arms, legs and tongue and he fainted. He was evaluated in an emergency room and was treated with prednisone and BENADRYL. The patient was seen in the office on 28-MAR-2013 and was found to be fully recovered. Additional information has been requested.
I started feeling ill a few hours after receiving both the flu shot and the pneumonia vaccine. I've never had a reaction to the flu shot, this was the first time I've gotten the pneumonia vaccine. My arm pain intensified throughout the night at the injection site and around it and I felt really bad, first a headache and then chills and muscle aches. By morning I was terribly weak and my joints and muscles were in terrible pain, I could barely walk a few steps without having to sit because I was so week. I would get the chills with my teeth chattering and then I would get so hot my skin felt like I could cook on it.  I couldn't get into my doctor on that Monday but by Tuesday I was still sick and my doctor instructed me to go to the hospital. They admitted me with a WBC of 15,000 and all my other symptoms. On Wednesday the 23rd my WBC had dropped to 11,000 and I was feeling a great deal better.  I still have the headache on 11/25 but other symptoms have subsided.
Blurred vision in right eye.  I first saw a physician on 12/28/09.  The blurring got progressively worse over the next few week.  By the middle of January I had lost approximately 50% of the vision in that eye.
Monovalent mRNA vaccine administered for a bivalent mRNA dose. Patient was given the monovalent mRNA vaccine, as I was not aware at the time, that the EUA had been withdrawal by the FDA.  My supervisor received noticed on 05/01/2023 from Health Department with a link to the Department of Health and Human Services  which announced updates to Covid-19 vaccines.  That the Bivalent Moderna & Pfizer BioNTec vaccines were to be used for all doses administered to those 6 months of age and older.  In the announcement, NO where did it state that this change had gone into effect the month prior. I was forwarded the email announcement  on 05/02/2023 and it was read on 05/03/2023 as soon as I returned to the clinic office from doing vaccinations I destroyed all remaining doses of our Pfizer monovalent mRNA FP7136 vaccine.  The patient suffered NO adverse affects and had NO adverse events following his vaccination. This patient was notified on 05/24/2023 regarding the need to have his vaccine repeated with the updated Pfizer Bivalent vaccine. Patient stated he didn't want to do it "just yet".  Patient still remains incarcerated in our custody and will be offered the Updated Pfizer Bivalent vaccine this week.
I received my booster and had break though menstrual bleeding the following day. My cycle was not due for 2 weeks. This is completely not normal for me. I also experienced menstrual changes after my first two doses. All three doses were Pfizer.
Information has been received from a nurse practitioner concerning a female patient (age unknown), who, on an unspecified date, was vaccinated with a third dose of GARDASIL. Subsequently, following the completion of GARDASIL series a pap test was performed that was "equivocal or invalid for cervical cancer." At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
pt recv vax 6DEC96 & 30APR(7 pt devel chickenpox described as a mild case w/fever;pt recovered;
After my vaccine on 03/17/21 I started experiencing a rapid heart beat and at time my heart would skip!  I reported this to the Covid 19 hotline immediately and also notified my doctor!  My doctor scheduled a visit and did an EKG and also ordered a heart monitor which I wore for two weeks.  The report from that went to Dr, a cardiologist at clinic where I was diagnosed as having Afib.  I was shocked since my heart has always been healthy and heart disease does not run in my family!  I was put on a beta blocker because of the concern of having a stroke!  A follow-up visit to discuss a procedure that will fix my Afib in scheduled for 06/22/21.
Patient's last menses was 4 April, she was vaccinated on 16 April and came in on 11 May with a positive pregnancy test.  This is to report in case any tracking is needed.  Patient has no adverse event at this time and was notified of the theoretical concern.
Patient was seen in ER 11/3/13 and 11/5/13 for bumps on top of head, hives and swelling from face to legs. After testing by allergist it was decided she has been having reaction to flu vaccine also fever 102.
One day post vax pt complained of swelling, itching and discomfort in his left  arm.  Parent noted a fine papular rash and hot area around injection site. Pt treated with Benadryl and ice pack. Three days post vax pt was improving.  The left arm still edematous four days post vax. No respiratory difficulty noted.
Ten days after the third dose of the vaccine I got my period during that time, and it was very unusual. I passed large clots and it was very heavy. It started heavily immediately instead of slowly. It lasted about 4-5 days which was normal for me. I normally do not have large blood clots during that time. I also had some GI distress during that time.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. It was reported that from 14-MAR-2016 to 16-MAR-2016, PROQUAD (Merck) (lot # reported as L034736, expiration date 09-DEC-2016; lot # L050909, expiration date 30-DEC-2016, lot # L046508, expiration date 17-MAY-2017) were improperly exposed to -12.97 Centigrade degree for 9.5 hours and -12.59 Centigrade degree for 9.75 hours and -10.79 Centigrade degree for 14 hours. Then, on unspecified dates after 16-MAR-2016 (in 2016), the patients were vaccinated with the improperly stored vaccine (dose and route not reported). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Pt developed erythema and induration to (R) thigh - 2.5 cm. Minimal warmth, some tenderness.
low grade-100 degree fever @ noc 5DEC94; hives few on lt arm & abdo 6DEC94 disappeared p/few hrs;
This case was reported by other health professional and described the occurrence of sick in a female patient who received FLULAVAL 2014-2015 season. On 10th October 2014, the patient received FluLaval 2014-2015 season. In October 2014, unknown after receiving FluLaval 2014-2015 season, the patient experienced sick, stuffy nose, running nose and bad feeling. On an unknown date, the patient experienced recurrent cough. On an unknown date, the outcome of the sick, recurrent cough, stuffy nose and bad feeling were unknown. It was unknown if the reporter considered the sick, recurrent cough, stuffy nose, running nose and bad feeling to be related to FluLaval 2014-2015 season.  Patient received the tri flu shot.
Affected area: back, itchy red, stinging - mild and unchanged Associated symptoms: erythema, painful rash and pruritus Treatment: gabapentin 600 mg 1 tb, PO, 2Xs/day counieling care, Valacyclovir 1 gram tab, PO. 5 days end: 6/26/23
2 days after shot (while walking on treadmill) chest pain and shortness of breath; pain in neck both sides radiating from chest burning; elevated heartrate and dizziness.
may be I am bleeding; have like a patches, like a little dots on my legs all over and they are so many; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Dec2021 (Lot number: FJ1620) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "may be I am bleeding"; RASH MACULAR (non-serious), outcome "not recovered", described as "have like a patches, like a little dots on my legs all over and they are so many".  Clinical course details: Patient took the Pfizer vaccine on 25Dec2021, first dose and today (date unspecified) from the morning, patient started having like patches, like little dots on legs all over and they were so many, and not disappearing.  Follow-up attempts are completed. No further information is expected.
Patient was given Moderna Bivalent Booster 0.25mcg, patient was to receive 0.5mcg. Wrong dose given
PATIENT SAID COLD, TINGLING, NUMBNESS LIKE FEELING IN ARM THAT INJECTION WAS GIVEN IN, NO ANGIOEDEMA PRESENT, NO REASH, HIVES OR REDNESS AT THE INJECTION SITE. VITALS WERE MONITORED. PATIENT ADVISED TO CONTACT PCP OR GO TO ER IF GOT WORSE. SHE WENT BACK TO WORK ON 6SOUTH AFTER 30 MIN WAIT TIME.  11:12 AM 134/91 HR 71 98% IN LEFT ARM, RIGHT ARM 124/88 HR 70 OXYGEN 99% 11:27AM 137/82 LEFT ARM, HR 72, OXYGEN 99%, RIGHT ARM 128/95 HR 65 OXYGEN 99%
Pain and redness at injection site, muscle aches, joint aches, fever, chills, fatigue, loss of appetite.
Tinnitus , hissing ringing in both ears. Went to ENT and had hearing test. Minor hearing loss. Recommended earing aids to mask Tinnitus.