chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 28 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6203), on 17Mar2021 as dose 2, single (Lot number: EN6208) and on 29Dec2021 as dose 3 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Petcus Excavatum" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Trazodone, reaction(s): "Known allergies: Trazodone", notes: Known allergies: Trazodone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 01Apr2023 to 06Apr2023, were taken as a result of vaccination failure, covid-19.
When Pt got the vaccine shot, his arm bled a bit unussually. The nurse wiped his arm. He stood up and said " this feels veryy strange and uncomfortable." aprcoximately 1 min after that, he lost consciousness and fell to the floor. His body was trembling, like twisting and he had his eyes open. I took off his mask so he could breathe better and i spoke to him but he didn't seem to respond. This lasted for about 1 min ( i could be wrong , time was strange in that moment).  Then he regained consciousness and some nurses sat him on a chair. He vomited, he was pale. The nurses laid him down on a bed for 30 minutes and then sent us home. After this, he has been apparently well.
A lot of blood vessel were highly visible in his center chest area. This adverse event disappeared after approximately five day.
Initial report received from a healthcare professional on 19 July 2013. A 32-year-old female patient, had received first intramuscular dose of ADACEL (Lot number U4612AA, anatomical site of vaccination was not reported) on 18 July 2013. The patient was pregnant at the time of report. The patient's last menstrual period date was 26 December 2012 and the expected date of delivery was reported as 02 October 2013. The patient's health during pregnancy, concomitant medications and risk factors were not reported. At the time of report, the patient had not experienced any adverse event. List of documents held by sender: None.
I have had very intense diarrhea for a week now since vaccine. i I was not aware of this as a listed side effect, but it started over 8 hours after shot and has continued for a week now.  I have taken Imodium and it has helped but the minute this wear off diarrhea returns. The thing is I just NEVER have diarrhea, in 67 years you   could count on 1 hand the times I have had mild diarrhea, never anything like this.  I would classify this as violet diarrhea.
2/16/2023 I woke up with a dry throat, cough and feeling tired. I tested positive with an at home COVID test. I called my physician and she prescribed PAXLOVID and said to stay home and quarantine for five days and then I could go out with a mask for five more days. I started taking PAXLOVID that day. After a few days, I felt better.
Pt claims that 24 hour post injection, injection site became red, raised, swollen, hot to the touch; pt claims she had a fever; pt seen by PCP day after inj. PCP advised pt to not get 2nd dose, pt started on KEFLEX 500mg tid x 7 days possible cellulitis?
cough; I got the flu shot a few days later I got the flu so bad; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via company through social media on  21-Nov-2020 .  This case involves a patient of unknown demographic who got the flu shot a few days later got the flu so bad (influenza) and cough, while while the patient was treated with INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2006 (latency unknown) after the initiation of the suspect vaccine therapy the patient got the flu shot and few days later got the flu so bad (influenza) and had to miss a week of work  On an unknown date in 2007 (latency unknown) after the initiation of the suspect drug the patient againg got the flu and cough and again had to had to miss a week of work.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
Patient was given the correct vaccine requested, was clinically indicated, and the interval between the previous booster and the booster that was given was correct.  However, the vaccine given to this patient was 5 days outside of its BUD (once removed from the freezer, they are good for 10 weeks in the refrigerator.....this was 5 days past that date).   We contacted Pfizer for guidance and were provided with clinical and efficacy data that suggested that the potency/efficacy could not be verified for that time window outside the 10 week BUD.  We provided this data from Pfizer to our clinical corporate pharmacist coordinator for guidance, and the recommendation was to re-vaccinate at no particular interval.  No harm was implicated,  and when we contacted the patient, she did not report any adverse effects.  She was amenable to re-vaccination once she returned from  travel.
Pfizer covid 19 **Patient was pale,  lethargic and sweating from forehead. After 45 minutes of observation, patient felt better and left.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 5 month old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral for, lot#J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
1/9/2021: 0230: Woke with headache and generalized muscle aches 1200: Generalized muscle aches, severe headache and blurry vision
Felt soreness at sight, L deltoid, immediately after injection, thought pain would improve, it did not.  It worsened kept her up at night and limited ROM.  Treated with ibuprofen, naproxyn, diagnosed with brachial plexitis and after 6 weeks still having some pain but improved.
He had a mild skin rash after the first dose; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient claims he had a mild skin rash after the first dose. He states this rash has still not resolved over two weeks later. He went to see his doctor and all of his blood tests are clean and he's not allergic to something. His doctor told him to drink benadryl every day, and he has been for two weeks but its not helping. His PCP suggested he call Pfizer for treatment. The patient underwent lab tests and procedures which included blood test: clean (he's not allergic to something) on an unspecified date of 2021. Therapeutic measures were taken as a result of he had a mild skin rash after the first dose. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recvd vax & had no appetite, fever 103.5, jerking movements & slept for a day & a half & had night mares; mom called w/this on 7JUN93;
Extreme pain in deltoid (right arm) also into a right elbow. Painful to use right arm with great (or any) degree of movement. This area was where flu shot was given. Right arm had minimal use due to pain. Yes itch. Need help relief.
Patient developed severe epigastric pain, nausea, diarrhea, urinary frequency 2 days after his Moderna vaccine. A medical assistant who saw him around day 14 said he looked jaundiced.
Pt resided in an assisted living facility. Spouse lives in independent living at the same facility. Spouse reports Pt tested + for COVID at the facility 01/19/2022 and had been in isolation. (no record of that lab)  Reports Pt fell 01/23/2022 and was transported to ED by EMS. Pt  tested + 01/23/2022. Admitted.  Cardiac Arrest occurred the afternoon of 1/29/2022.  Web report state patient has been stable and awaiting placement, asymptomatic for the past 3 days. Seen around 1 hour prior to event
Pt CALLED ON 9/19/17 IN THE LATE AFTERNOON SAYING SHE WAS HAVING A REACTION TO THE VACCINES GIVEN THE DAY BEFORE. SHE REPORTED SWELLING, KNOTTING REDNESS AND PAIN AT THE SITE OF INJECTION. THE REDNESS AND PAIN LATER SPREAD T0 THE INNER ARM AND ARMPIT AND ON 9/20/17 SHE REPORTED HER BREAST WAS TENDER ALSO. THE CLINIC WAS CLOSED AT THE TIME SHE CALLED THE PHARMACY, SHE SENT A PICTURE (AS SHE LIVES 30 MINUTE DRIVE AWAY)  BUT THE PICTURE CAME ACROSS BLURRY. I SUGGESTED SHE ICE IT AND TAKE TYLENOL FOR PAIN AND SWELLING. ALSO TO TAKE BENADRYL THAT NIGHT AND IF NOT ANY BETTER TO SEE THE DR. THE NEXT DAY, I ALSO SUGGESTED DRAWING A CIRCLE AROUND THE REDNESS TO SEE IF IT IS SPREADING. SHE CALLED MID MORNING ON THE 20TH SAYING THE SWELLING AND PAIN WENT DOWN BUT WAS STILL RED AND THE REDNESS WAS OUTSIDE HER CIRCLE SHE DREW. I SUGGESTED HAVING A DR. LOOK AT IT AND SHE WENT TO THE CLINIC AND THE DR. SAID IT LOOKED LIKE SHE WAS HAVING A REACTION TO THE PNEUMOVAX VACCINE.  HE PRESCRIBED BACTRIM DS TO BE TAKEN TWICE DAILY FOR 5 DAYS.
Patient was given Flu Vaccine yesterday and age was overlooked.  Patient was given Flu Mist at age 50.
"This is a 39 yo woman who states she works  , received second dose of Covid 19 vaccine on 02/23/21: was achy and nauseated which resolved with Tylenol. Denies cough, runny nose, sore throat, SOB, wheezes, lack of smell or taste. Denies exposure to Covid19 patient or suspected. Works in person."
6 year-old chile received Pentacel as 5th dose in DTaP series; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old patient who received 5th dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and Fluravada.  On 17-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot #UJ157AAA, exp; 2/3/2021) at a dose of 0.5 ml via intramuscular route in the left vastus lateralis.  It was a case of actual medication error due to inappropriate age at vaccine administration  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 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.
After the first shot, the second day my period came earlier than usually at least 3 day compared last month, my period usually will not come early. Then after shot the forth day morning, I got up and looked into the mirror, I found eye bloodshot on my right eye (white eyeball), it took around 2 days then the bloodshot was absorbed.
Patient developed sudden onset of abdominal pain 3 days after her second shot, which progressed and on 5/28 she presented to hospital with acidosis and acute surgical abdomen.  She was found to have bowel ischemia and taken multiple times for exploration and resection - 5/29, 5/31, 6/2, 6/5, 6/7, and 6/9.  She had a prolonged course in the ICU and hospital and was discharged to home on 7/14.  However, patient developed short gut syndrome and enterocutaneous fistula, now TPN dependent.
Information has been received from a physician concerning a 14 year old male who on 23-AUG-2007 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck). On 24-Aug-2007, the patient developed a localized cellulitis rash at injection site. The patient sought unspecified medical attention. Subsequently, after therapy was stopped, the patient recovered. Therapy was not reintroduced. Additional information has been requested. The same physician also reported on the experience of the patient's brother WAES# 0709USA04222. Follow-up information received from the physician indicating that the patient was a 14 year old male who on 23-Aug-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot#658197/0853U) in the left deltoid (IM). No concomitant medication was reported. The patient received 1 previous dose on an unknown date. ON 24-Aug-2007, the patient experienced erythema/warmth and induration at the vaccine site measuring approximately 8 X 5 cm. No tenderness or pruritus was reported. It was a local reaction at the vaccine site, treated with Benadryl every 8 hours X 1 to 2 days cold compresses. The event resolved on 26-Aug-2007. No further information expected.
Swollen arm, sleeplessness due to arm pain. Pain radiates from injection site to hard blurry vision watery eyes took TYLENOL which alleviated some pain, but recalls onset of blurry vision upon taking TYLENOL.
Soreness at injection site Fever of 100 degrees Chills Body Aches Tiredness  At 8:00 pm on March 3 I took 1 full dose (325 MG) aspirin.  By the next morning,  all symptoms except tiredness were gone.  Tiredness  remained on March 4, but was gone by March 5th, 2021
I received the Pfizer/BioN Tech Bivalent booster on 10/3/2022.  Previous to this injecting I had the Moderna shot March of 2021 and the Jassen shot September of 2021.  I had the typical aches and arm pain 10/3 - 10/6 with the Pfizer booster. The length in time and overall negative effects  of the Pfizer shot felt stronger then I experience with the Moderna and Jassen shots.  Aleve was taken 10/4 - 10/6 to reduce aches and discomfort.  By 10/7 I was fell almost 100% (back to normal). Arm pain was not present. General body aches had disappear.  On 10/8, 3:00 AM, I was awaken from a sound sleep with extreme Paroxysmal Atrial Fibrillation. My heart felt like it was going to  jump out of my chest.  pulse over 140. 155/100  I went to ER. Symptoms were relieved by 14:00 via chemical conversion.
Patient had swelling and red rash around injection site that was warm to the touch.  She went an urgent care clinic on 11/15/2019 and was perscribed cephalexin
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on an unknown date, the patient was administered ZOSTAVAX vial that had been improperly stored (dose, route and lot number not provided). No adverse effects were reported. This case was linked to case MARRS # 1504USA022603 (same reporter link). Additional information is not expected because the reporter did not provide consent to follow up.
Multiple adverse events. Most serious is the Swelling of the left knee cap area starting on Day 4 (1/29/2021), extremely swelling and pain left knee 1/30/2021, 1/31/2021, 2/1/2021 and reduced swelling 2/2/2021. Went to PCP on 2/2/2021 was referred to hospital for x-rays of left knee. Also right foot and leg were swelled on 2/2/21 and 2/3/21 the same area of prior Achilles Tendon surgery May 2018 and history of DVT Blood Clots June 26, 2018. Still experiencing swelling to left knee and, left ankle now and right ankle swelling.  1/26/2021 at 4:05 pm had charley-horse pain at right posterior thigh area left of hamstring from 4:05 pm to 4:15 pm then it disappeared. 1/26/2021 8:00 pm to 10:00 pain to right quadricept area then disappeared. 1/26/2021 around 4:30 pm to 1/29/2021 10:00 pm had random Itchyness episodes for 15 seconds then ok for a minute then 15 seconds itchy someplace else. The worst of the itchyness was for the first 48 hours.
Bone pain throughout body within 6 hours of shot. High fever, headache, nausea, joint pain, cold sweats, exhaustion within 12 hours of shot. lasted 24 hours.
This medically confirmed spontaneous report (initial receipt 26-Oct-2012) concerns a female patient. On 27-Sep-2012 the patient received AFLURIA (batch number: P58306) injection intramuscularly. After the AFLURIA injection, the patient developed pain in the arm where injection was received. The date the pain started was unspecified. The patient sought medical attention by seeing her pharmacist. No lab diagnostic study was performed. No treatment was given for the event. The event outcome was recovering.
Patient said arm was swollen and she was complaining of being tired and achy all-over.
Dehydrated, vomiting, diarrhea. Nurse follow up on 06/08/04 states: Fever, joint pain, headache, site edema.
Patient did not suffer any adverse effects.  He received monovalent vaccine instead of the bivalent Moderna booster that he was due for.
Swollen Lips, numbness on upper and lower of mouth(chin) and numbness on forehead.
mom described child sx 2wk p/vax pt had problems walking then was unable to sit on toilet;took pt to ER then to MD who hosp for 10 days;mom states pt dx w/GBS
Crippled by the vaccine; Can't do job no longer; This spontaneous case was reported by a nurse and describes the occurrence of PHYSICAL DISABILITY (Crippled by the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHYSICAL DISABILITY (Crippled by the vaccine) (seriousness criterion disability) and IMPAIRED WORK ABILITY (Can't do job no longer). At the time of the report, PHYSICAL DISABILITY (Crippled by the vaccine) outcome was unknown and IMPAIRED WORK ABILITY (Can't do job no longer) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (disability) event of Physical disability and non-serious event of Impaired work ability unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was crippled after the vaccination and can't do her job. No further details on clinical course, other lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (disability) event of Physical disability and non-serious event of Impaired work ability unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was crippled after the vaccination and can't do her job. No further details on clinical course, other lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vaccine received around 10:45 a.m. on Monday, March 8, 2021.  Headache started on the night after the injection (Tuesday, March 9, 2021). On Wednesday, March 10 headache continued, because nauseated, felt lightheaded.  Symptoms/side effects lasted the entire day.  Excedrin did not alleviate headache, which is very unusual for me.  I did not take anything else for the headache and did not attempt to treat the other symptoms/side effects.  On Thursday morning, March 11, all symptoms/side effects were gone.  No recurrence.
pt went to the ER on the following day. His dr told him they are not sure if it is related to the vaccine or not. Pt had fever headache and HBP
Patient to receive (Grey Top) Adult 30mcg/0.3ml Booster Dose and received the (Orange Top) diluted 0.2ml. This was discovered upon entering the data into the data base. No adverse reaction was noted. State was contacted and recommended repeating correct dose. Mother notified by the Quality Program MD.
pt recvd flu vax & 2 wks later exp flu-like sx; pt wishes to reamin anonymous, & did not provide name or MD info;