chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given MMR  instead of MMRV. This was realized on 3/21/22 during a vaccine count.  Lot # of vaccine administered was  determined to be MMR and not MMRV. (The packaging on MMR and MMRV are very similar and the vaccine locations were switched in the fridge on accident). Patient's mother was contacted as soon as mistake was realized. Appt scheduled 4/11/22 for varicella vaccine.
Tachycardia  SPO2 below 90% and elevated HR. Pt. stated able to breathe but feeling slight tightening of her throat, SOB. Sent to the ER for eval  Narrative:
Headache, Myalgia, Arthralgia, NauseaVomiting, dyspnea, Narrative:  Advised by md not to take the second vaccine  Other Relevant History:
MILD TINGLING TO LEGS; This spontaneous report received from a patient concerned a male 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, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the subject experienced mild tingling to legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild tingling to legs. This report was non-serious.
I had the flu shot administered by the local county health dept. at 2:30 yesterday.  At 10:30 I became feverish, nausea (vomited) then chills.
The patient received the first two doses of injection, with no apparent untoward effects. On 04/05/2000, he received the third dose and approximately one week later tested positive for rheumatoid factor and had an elevated erythrocyte sedimentation rate and and elevated Lyme titer blot for Lyme antibody. Upon physical exam, the patient had a diffusely swollen tender wrist with decreased range of motion in all planes. The exam was not consistent with isolated ligament tear or cartilage injury, but appeared to be an acute monarticular inflammatory arthropathy. Treatment included Medrol intrarticular injection of cortisone. The information received on 05/06/2000 reported after the cortisone injection the symptoms almost completely resolved.
The patient recently had titers which showed she was not immune.; Caller also thinks the patient may have received dose 1 too early; This spontaneous report was received from registered nurse and refers to a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, as child, the patient was vaccinated with 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided) for prophylaxis. On an unknown date (reported as recently), the patient had titers which showed she was not immune to varicella (antibody test negative). The reporter thought that the patient might have received dose 1 too early, but did not have any more specific information on timing of that dose (inappropriate schedule of product administration). The outcome of the event was unknown. Action taken was not applicable.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Difficulty swallowing/ sucking.  Newborn was unable to nurse for 3 days after, had major difficulty with nursing for about a week after.  Irritable and had a rash that ER doctor said was not allergic reaction.  Same reaction was seen at 2 month hep B vaccine.
24hrs p/vax c/o generalized itching & SOB;rx DPH;SOB resolved rash & pruritus spread from rt arm @ inj site to rt neck & face; given Medrol; hypersensitivity to Hep B vax;
at 2:30pm pt had temporary loss of consciousness for approx. 15 seconds pt. was safely assisted to gurney and placed in supine position with BLE elevated. vitals monitored VS BP 97/67 P-65 RR-17 o2SAT 97% RA pt offered fluids and snacks pt refused snacks pt had water. 230pm pt denies dizziness no headache no SOB no lightheadness vitals BP80-/50 17,69, 98%RA 245pm pt bp still cont. to be below normal. bp 87/57 P-63 RR-18 o2SAT 97% RA  pt was recommended to sent to hospital for further eval. 255pm 911 came and elaluated pt per paramedics based in theri eval. pt. &mother was made to choose to go to the hospital or go home pt. and mom choose to go home.   #23 Syncope  #21 went home against med advice
She has had diarrhea for 14 days and it is worsening.; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EW0176, expiration date 01Aug2021) via unspecified route in the right arm, on 27May2021 (at the age of 64-years-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that after the first dose of the Pfizer COVID shot on May2021, she has had 14 days of diarrhea real bad. Patient received her first dose of the Pfizer Covid-19 Vaccine and has a question about the side effect Diarrhea. She has had diarrhea for 14 days and it is worsening. She is asking how long the diarrhea will last. She stated that she talked to her Pharmacist and he recommended a medicine for her to take and she is still having diarrhea. She was wondering if there was anything she could take to help with the diarrhea because that was embarrassing and her rectum was raw and when it hits, she does not know if she had time to make it to bathroom. Pharmacist recommended her to take for the diarrhea Loperamide Hydrochloride Lot number 977532, Expiry Oct2022. Patient had no other vaccines on the same day as the suspect product. There was no emergency room or physician office visit required for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Description of complaint included patient who experienced an adverse event to the suspect product COVID shot and while completing a safety report on that suspect product, caller mentioned that her Pharmacist recommended that she takes Loperamide Hydrochloride for diarrhea, and she states that her diarrhea is not getting better. query mentioned Start date for 1st dose was given as 27Apr2021 and 27May2021. Kindly, confirm the start date of 1st dose. Response After reviewing the call recording it was confirmed the first dose was given on 27May2021. This was populated incorrectly by the call handler in the designated field. The clinical outcome for the event was not recovered.  No new information received. No follow-up attempts are needed. No further information is expected
This spontaneous report was received from a medical assistant regarding a 8 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 15-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # 029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Soreness at the injection site for about  3 days Diarrhea, began 02/11/2021, 10 AM and lasted through 02/13/2021, 5 PM.
Information has been received from a registered nurse concerning a 14 year old female with diabetes who on 22-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 658558/1061U).  Concomitant suspect vaccination included Varivax.  On 22-AUG-2007, the patient became pale, light-headed and almost fainted.  Unspecified medical attention was sought.  On 22-AUG-2007, the patient recovered from becoming pale, light-headed and almost fainting.  Additional information has been requested.
I got my injection about 6 hours later my arm started to feel completely broken from shoulder to fingers. I could not move it without intense pain for a few days. Then pain followed off and on that felt like I hit my funny-bone perpetually. 5 weeks later, the pain became so bad that I went to the ER for treatment. I also had an x-ray done earlier in the week for it at an orthopedic clinic who told me the injection was injected too high and into my bursa. They scribed PT. But when in ER, My arm started to go completely numb. I then received steroids to take 5 days orally. The pain has gotten a little better but I have limited movement without feeling nerve pain all down my arm into my fingertips.
Patient reported lower back to be very painful and to "lock up"; patient reported that it was rather difficult to move.  Patient has been to the chiropractor and reports that is helping his locking up and lower back back.  The pain radiated down the right arm and to the chest as well.  The arm pain and chest pain are getting better about 2 weeks later.
w/in 24 hr p/vax arm swelled; sl fever lasted 3 days; swelling spread to underarm & side of breast, but has disappeared; swelling & pain still present lt upper arm; pain occasionally spread & causes tingling sensation; taking Naproxen;
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 77-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a year after receiving SHINGRIX, the patient experienced feeling unwell, walking difficulty and muscle pain. On an unknown date, the outcome of the feeling unwell, walking difficulty and muscle pain were unknown. It was unknown if the reporter considered the feeling unwell, walking difficulty and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was a friend of the patient from her walking group. The patient told her that she had the first dose of the SHINGRIX vaccine sometime in late April 2018. The patient did not walk on the last Tuesday because she was not feeling up to it. On 5th Jun 2018, the patient returned to walk with the group. The reporter noticed that the patient was walking only a little distance, so she told the patient that she was concerned because of that reason and because the patient had not felt up to walking with the group. The patient told her that she has been having funny pains which felt muscular. The reporter said the patient might call GlaxoSmithKline in the future with further details. The reporter's friend was already scheduled for the second dose of the series and was beginning to wonder if the symptoms could be due to the first SHINGRIX dose and was now concerned about receiving the second dose in the series. No further information was provided. This case has been linked with US2018100625 and US2018GSK101152 reported by the same reporter.
Patient received Pfizer at pharmacy in February 2021. Patient came in and didn't have card at the time of administration on 8/5/21 and didn't know which vaccine she had gotten. Patient received Moderna.  Patient came in on 8/19/21 when she had found card and pharmacy realized she had gotten one dose of Pfizer and one dose of Moderna.
Left arm with immediate itching and soon to follow redness, swelling & warmth.  BENADRYL given & Ibuprofen.  Seen in office on 8/3/09 for eval.  Mother concerned for component allergy.
Small red spot increased in size; Low grade fever; A spontaneous report was received from a consumer who was also a female patient who received Moderna's COVID-19 vaccine on 15 Jan 2021 and experienced small red spot increased in size and low-grade fever. Patient's medical history and concomitant medicines were not reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced small red spots increased in size and low grade fever and took some aspirin after. Treatment included Aspirin Action taken with mRNA-1273 was not reported. The outcome of the events, small red spots increased in size and low grade fever  was considered unknown.
It started with 2+ Disc Edema followed by 22 days of low grade fever and a lose of 17 pounds. Sysmptoms that followed include red eye (Scleritis) and shaking hands.
Bad reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he patient had bad reactions to the Shingrix vaccine. The reporter did not consent to follow up. The reporter has no other information for this adverse event. This case linked with US2019179915, reported by same reporter.
2/20/03 approx 18:00 noticed small red bumps on back, chest and arms. No itch, no swelling. Seen in a medical clinic this a.m. (2/21), referred to ER, Dx'd with generalized vaccinia. No medications given. No quarters, released. Return if SXs worsen.
79-year-old male with a history of chronic obstructive pulmonary disease, atrial fibrillation, gastroesophageal reflux disease, oral cancer, lung cancer for Which he follows with his oncologist and status post chemotherapy with last treatment approximately 2 weeks prior to admission after which he reported he had progressively worsening shortness of breath and associated weakness, chills, productive cough with thick green sputum, for which he presented to the emergency room on 01/12/2022. He went to see his PCP on the day of admission when his symptoms did not improve and was found to be in atrial fibrillation with rapid ventricular response, and EMS was activated for transport to Medical center.  Upon arrival to the emergency room; he was found to be hypoxic and placed on supplemental oxygen and tested positive for Covid-19.  He was given diltiazem in the emergency room and admitted to the Covid step-down floor.  He continued to require increasing amounts of oxygen despite being placed on remdesivir, steroids, vitamin C, and zinc.  Transferred to the intensive care unit due to ongoing worsening respiratory failure. Pulmonology was consulted on 01/14/2022.   Patient was intubated on 01/15/2022 and never came off the ventilator. He remained with low oxygen saturations in the 80s. He did get treated with baricitinib as well for the COVID-19.  Patient expired on 1/23/22.
This 91 year old white male received the Covid shot on   2/19/21 and subsequently died on 3/21/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation..
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2020 as dose 1, single (Lot number: 5130), on 08Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 27Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa, penicillin; "Hashimotos" (unspecified if ongoing); "Familial Hemiplegic migraine" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; OREGANO OIL; MOTRIN [IBUPROFEN]; TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) positive, notes: Confirmed positive via PCR 20Apr2022; (19Apr2022) positive, notes: Positive on rapid antigen; (27Apr2022) Negative, notes: Negative rapid antigen tests on 27Apr2022 and 28Apr2022; (28Apr2022) Negative, notes: Negative rapid antigen tests on 27Apr2022 and 28Apr2022; (30Apr2022) positive, notes: Positive rapid antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Rebound infection. Symptoms began 18Apr2022. Tested positive on rapid antigen 19Apr2022. Started Paxlovid 20Apr2022. Confirmed positive via PCR 20Apr2022. Finished Paxlovid course on 25Apr2022. Symptoms resolved 27Apr2022. Negative rapid antigen tests on 27Apr2022 and 28Apr2022. Return of symptoms 29Apr2022. Positive rapid antigen test 30Apr2022. Patient had received anti-viral treatment of Paxlovid from 20Apr202 to 25Apr2022. It was reported that patient had received Other medication in 2 weeks.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Information has been received from a physician concerning a 4 year old male patient, who on 24-Feb-2005, was vaccinated with VARIVAX (Merck) (LOT #648318/0440P) in his left arm SC. Subsequently, his parent called office reporting rash on back and chest which were defined as pimples with raised center. On 04-APR-2008, the patient was seen in office. It was reported that he broke out in a rash prior to starting antibiotics yesterday (03-APR-2008) for otitis media. The physician stated that tympanic membranes were thick and dull. He had about 12 lesions which would be best described as a vesicular rash in various stages of eruption and scabbing. The physician reported that he certainly quality for chicken pox. He was diagnosed as post vaccine chicken pox. The physician told the parents he would probably only break out for about 3 days with less than 50 lesions. He would only be mildly ill. The patient was to continue to ZITHROMAX for his otitis media. The physician also wrote a note for him to return to daycare on 07-APR-2008. Subsequently, the patient recovered. Additional information is not expected.
- Woke up in the middle of the night following the day of my shot, approximately 14 hours after injection, to the shivers. Whole body shaking, almost feverish, but without running a temperature. - Severe fatigue the entire two days following the injection. Slept for 21 hours beginning on noon the day following the shot until 9am the following day. - Mental haziness/fogginess three days after injection. Felt as if I was buzzed without having consumed any alcohol.
Very sore at injection site. A few hours later just felt bad in general. Went to bed at night and when I woke up the next morning I had chills and ached all over. Bad headache. I felt like I had been run over by a truck. Slept most of the day. Woke up feeling better, but not great. Had dinner. Just very sore all over now with slight headache. Also, my heart rate is higher than it normally is but still within normal parameters. NOT looking forward to #2.
Date of injection 11-21-11 approximately 2pm. Pt developed pain and severe limitation in ROM. It is starting to improve. Unspecified adverse effect of unspecified drug, medicinal and biological substance noted. Patient presents for evaluation of pain. This pain is localized to the right shoulder and upper right arm. it does not radiate. It began 2 weeks ago. The onset of pain occurred received a PNEUMOVAX vaccine and pain started two hours later. The next morning she noted mild swelling. She characterizes it as aching and dull. It is of mild intensity. Aggravating factors include lifting and movement in general. Pt was unable to abduct or extend the arm far enough to apply deodorant for a week. She went to the emergency room where an xray was performed (it was negative). She found the prescribed arm sling was not useful. The pain is relieved with Ibuprofen and TYELNOL #3 gave an upset stomach. She finds arm movement is helpful. Associated symptoms include weakness in arm. No swelling, bruising, redness or warm to touch.
Pt described starting to have warm, red, swollen, tingly fingers on both hands and felt that her ears and back of her neck were hot/red.  Upon examination - there was no warmth or redness noted on ears or neck; lungs were clear to auscultation.  Her hands were a little pink but did not appear swollen.  She was able to drink a large cool water and said holding the container in her hands felt good.  She also noted her lips were a little tingly.   A decision was made to offer her 25 m.g. benadryl p.o. - and she felt some relief within ~ 20 minutes of dose.  She was able to return to work but did note she developed a headache and did take excedrin for that.  Since this initial episode - she has felt extreme fatigue and body aches and those appear to continue to today (29Dec2020).  She also has been experiencing chills and some itching on her torso.  She also reported starting to have a bit of a cough and sore throat - so will see if she should go to COVID testing.
THIS PATIENT WAS GIVEN THE VARICELLA VACCINE AT 1 YEAR OF AGE & AT 5 YEARS OF AGE CONTRACTED CHICKEN POX.
"LD sore & swollen under arm pit, and has red raised rash" this was per pt - did not see pt - school RN stated pt is fine.
Arm pain immediately after injection - sore arm, whole arm felt heavy  4 hours later - headache  At about 5:30pm - slight fever, slight chills 6:30pm-7:00pm - high fever, terrible chills, widespread body aches, delirium, nausea, extreme weakness, bed ridden  The following day - weak, body aches, loss of taste
Pt lost eye contact, he appeared to have lost his hearing. He began to walk in circles bucking his head up and down making strange noises. He discontinued his "babbling" and he started hitting himself in the head, banging his head on the floor or wall and flapping his hands.60 day follow-up dated 11/01/00 provided no additional data.