chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 20May2021 (Lot number: EW0186) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1, Lot number: EW0175), for COVID-19 immunization, reaction(s): "burning/tingling in my entire arm", "Chills", "Fatigue", "Headache", "Sweating", "swollen lymph node in my left armpit the size of a grapefruit", "Nausea", "Aches", "burning/tingling in my entire arm", "Fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". The event "sore arm" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She had a reaction of similar proportions to the second dose, which she was still trying to recover from now. She had chills, aches, headache, nausea, sore skin, fatigue & once took the shot in is the size of again my lymph made in the arm she had grapefruit, swollen & painful. Patient stated please consider with a lesser dose for people who had Covid or are Centre a certain weight. She felt there should had been an option for her to have a blood draw after the first dose useful scored high enough in antibodies. She could be considered fully vaxed. after one dose since she had Covid previously. stated it was healthy for her to have to go through that again or she would not be considered fully vaccinated. No follow-up attempts are possible. No further information is expected.
Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Formulation of Humira was reported as Solution for injection in pre-filled pen.  On an unknown date patient experienced flare ups.  Reporters causality of events with Humira was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
On 10-7-2023 pt received Fluzone HD in error instead of Fluzone. Pt. not yet 65, will turn 65 on 12-10-2023. No adverse effects/symptoms reported on 10-7-23 day of administration. 10-26-27 - Called pt. for follow up, no answer left message to contact clinic. 10-27-23 - Called pt., no answer left message to contact clinic. 10-30-23 Called and spoke with pt. , he reports pain at injection site for 3 days after receiving. Reports some redness at site, no discharge, or swelling, headaches, dizziness.  Reports shortness of breath but states he had this prior to Flu shot and is currently waiting to be evaluated with further diagnostic testing.
On 2/7 noticed itching at the site with redness neither of which happened until that date and they persist to the time of this report.
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/21/2021 with Pfizer ER8736 IM in left deltoid.
Administered to the patient outside the recommended manufacturer recommendations and FDA approved age range of 2-49 years old. Patient age is 58.
Several days after receiving the vaccine, I began experiencing nose bleeds from my right nostril.  Only occurs during the evening around bedtime or while I'm sleeping, and occurs every other day.  Blood is a steady stream that begins with no warning.  Blood flow stops after I push tissues up my right nostril and apply gentle pressure for 15 minutes or so.  I have never experienced this before.
didn't work for me either. Within a year ( lifetime shot) I had Shingles; had Shingles. I have had them twice; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, Shingles vaccine did not work for the him/her either, within a year (lifetime Shingles shot) the patient had shingles. The patient said that, he/she had them twice. The internist said that, the patient was not a candidate for vaccines. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. The case had been linked with US2021AMR101908, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101908:IDM response comment
On 10/29/2022 in the morning I woke up coughing. I thought I just had a cold. The next day on 10/30/2022 I started feeling sick and I was coughing more. On 10/31/2022 I was feeling the same symptoms along with severe cough. I took 2 home COVID-19 tests which were positive, and I also went to the pharmacy for a PCR test which was positive too. I messaged my doctor after testing positive. A nurse from her office reached out to me and advised me if my situation gets worse to go to the ER. On 11/01/2022 I was feeling very weak. I couldn't even stand up. On 11/02/2022 I was having diarrhea. I took over counter MUCINEX. On Monday I woke up with a headache so for all my symptoms I started taking TYLENOL, vitamin C, vitamin D, zinc and MUCINEX. I'm recovering from COVID-19, but I still have lingering cough and chest congestions.
experienced arm pain after first vaccination; This is a spontaneous report received from contactable reporter (Consumer) from a sales representative. The reporter is the patient.  A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experienced arm pain after first vaccination". Additional Information: The patient was reported to be approximately 180lbs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu vaccine administered 11/14.  Patient fell ill early on the 15th.  Had headache, sore throat, and achy muscles and weakness.  Was sickly 5 days.  Took Tylenol.
FEVER TO 100.4 24 HOURS AFTER VACCINES GIVEN. C/O CONGESTION. NO SITE DISCOMFORT.
Client reports that 3 days after he received his first primary Covid-19 vaccine, he experienced bilateral leg pain, leg weakness, leg numbness and tingling, headache, chills/fever, and sweating. Client reports that he spent multiple days in the hospital trying to figure out the cause.  Client presents with documentation from PCP with recommendation to wait on receiving 2nd dose of primary until he is further evaluated from a specialist. Patient reports the doctors told him his "white blood cells were attacking his body" per patient report.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) antibody test was done on patient and antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not report any adverse events or symptoms. No concomitant medication and treatment information was reported.   This case was linked to MOD-2021-415889 (Patient Link).
she uses a walker so she is not real fast; Infection/low grade infection; slight elevation of white blood count; has a lot of health issues; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on [10Aug2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) received via a female patient of an unspecified age received BNT162B2 (Lot Number: EN6200), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that patient felt uncomfortable on receiving vaccine due to a rumor in her area that a schoolteacher received the Moderna vaccine and died. Patient stated that she is holding off on taking second dose of vaccine. she already received the first dose six months ago. On an unspecified date in 2021, last month she had lab work and it showed slight elevation of white blood count, indicating an infection, a low grade one, but it was not clarified, where the infection was. It was explained that she goes to the doctor all the time and has not had a fever at this point. But her lab work will not be repeated until in Oct2021. She wondered if she would get a recommendation on getting the vaccine while her lab work is showing the infection. She also had a lot of health issues and were related to side effects; well she feels like that every day, so she didn't want to make things worse, so, she missed the second dose, as she didn't want to take risk. She also reported that from an unspecified date, she uses a walker, so she was not real fast.The patient underwent lab tests and procedures which included, on an unspecified date in 2021, investigation: slight elevation of white blood count indicating low grade infection.  The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.  Follow-up (10Aug2021): New information from a contactable female consumer (patient) includes: the case was updated as valid, new events added.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Runny nose, loss of taste and smell, headache, cough Tested positive for Covid 8/19/2021
5pm without realizing it I was feeling chest tightness,  tight throat and difficulty breathing within minutes I   had  rapid palpitations and my blood pressure was 158/97 .
High grade fever, diarrhea, vomiting, chills. 7 day course, Motrin and Advil.
PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM.  EPI 0.3MG ADMINISTERED AT 7:50AM. SYMPTOMS IMPROVED, BP 179/79 HR 114 AT 7:53AM. PATIENT REFUSED AMBULANCE OR FURTHER MEDICAL TX. STAFF MEMBER OBSERVED FOR AN HOUR UNTIL FAMILY ARRIVED.
Approximately 4 days after vaccination, patient reported increase pain, swelling and redness at site of injection. Seen by Infectious Disease MD. No antibiotics prescribed. 2x2 cm induration noted L deltoid.
patient said she was fine for "a couple days" then started having trouble getting a deep breath. She said it was getting progressively worse. I recommended she seek medical attention immediately.
See attached form. On January 13, 2012 patient received a TDAP vaccine at clinic. Within 3 days she noticed that she was having difficulty finding the right words at a business meeting and was physically feeling ill. By Thursday 1/19/12 she had a very bad headache and her neck was very stiff, had blurred vision at the computer and had sensitivity to light and sound. Currently her vision is still impaired, has poor memory, personality change, tremors, diminished right Achilles tendon reflex, her tongue has tremors and drifts to the right, and has word fluency problems. Previous to the vaccine she was a high functioning individual working as a marketing manager and on air personality.
5-01-07 Bumps on face, worst that evening, spread to neck, chest, back, buttocks, legs, behind ears. 5-02-07 Spread to scalp, palms of hands and feet. Saw physician - Blood test showed, increase lymphocytes. Augmentin administered April 25-May 01 for bilateral ear infection diagnosed April 25. Temp 101.8 (April 25).
This was a gradual thing. The first event was not as traumatic as it continued to be for 3 months. Cause it took me almost a month to figure out because I just kept getting worse. I went for 1.5 walk and when I got home I was so tired I collapsed on the sofa and couldn't get my breath. And that was pretty much it and I fell asleep. Then it just kept continuing everyday if I tried to do physical activity I would have the same thing happen and it just kept getting worse till the day I went to local memorial hospital which was a month later (maybe) what had precipitated that was that I was feeling shortness of breath and my heart felt like it was beating very fast. So my experiences were extreme fatigue and then over the course of that month and the few months I kept getting brain fog and actually thought I was getting dementia. I couldn't figure out how to do the simplest of things. I wasn't able to work, I could only do something for an hour and have to come home, this went on for 3 months. I thought I was dying. Which caused me to get depressed because it was so frightening.
After receiving the vaccines, the patient asked for some water. Writer was about to get water when the patient's eyes rolled back and she fainted. Patient was sitting in a chair - patient did not fall or hit her head. Writer stayed near patient to make sure she did not slide out of the chair and called for help. Patient came to less than a minute after fainting. Once able, staff assisted patient to a lying position. Patient stayed in the office for approximately 25-30 minutes to ensure she was stable and steady.
Patient c/o light headedness/dizziness during post - vaccine monitoring. BP: 89/56 P: 72 SpO2: 96% on RA.  Patient monitored for extended time.    2:50pm Patient verbalized resolved symptoms, BP: 114/70 P: 75 Sp)2 100% RA.  Patient assisted to vehicle and d/c home.
pt recv vax;sl n & warm sensation; some tingling sensation of chest & felt sweaty; feels better on 28apr95 w/ some sz;
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of neonatal hypoxia in a neonate female subject exposed to FLUARIX (GlaxoSmithKline) transplacentally when her mother was vaccinated during pregnancy. On 14 October 2011 at 11:00, the 28-year-old mother of the subject received unspecified dose of FLUARIX (.5 ml). Date of last menstrual period was 02 May 2011. The estimated date of delivery was 05 February 2012. The neonate was exposed to FLUARIX at 24 weeks gestation during the second trimester. On 17 January 2012, at 36 weeks and 6 days gestation age the mother was induced due to gestational hypertension (see case A0952841A). The neonate was born via normal vaginal delivery, weight 3420 grams, length 51 centimeters, head circumference 31.5 and Apgar score of 8/9. The neonate was transferred to higher level of care due to persistent hypoxia immature lungs. The outcome of the neonatal hypoxia and fetal lung immaturity was unknown. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Please see report A0952841A for details regarding the mother case.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. From 24-MAR-2017 to 06-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # L046884, expiration date: 23-NOV-2017 for prophylaxis. The patients experienced no adverse effects. Administered doses of vaccines experienced the temperature excursion of -14 to -10 degrees Celsius for 7 hours 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003016:
Information has been received from a nurse on 30-SEP-2008 concerning a 20 year old female with penicillin and sulfa allergies, and a gynecological history of Pap smear in 2005 who was vaccinated with a third dose of GARDASIL by a pharmacy. Subsequently the patient experienced pain in left shoulder, radiates down to the arm, increases with movement, aggravated by sleeping on the same side, weakness, started after vaccination one month ago and has not gotten any better. The patient's family history included both parents' kidney/bladder problems. Assessment of this event was joint pain, shoulder (primary). An X-ray in left shoulder was performed. Follow up information has been received on 02-OCT-2008. It was reported that the patient continued to have pain in it shoulder with ROM and is painful at rest. Medications for the event included ibuprofen 600mg 1 tab (s) QID, VICODIN 500mg-5 mg 1 tab(s) Q4H. Assessment were joint pain, shoulder (primary), and disorder of tendon of shoulder region NOS, left intraspinatus partial tear. A MRI in left shoulder was performed. Follow up information has been received on 10-OCT-2008. It was reported that the patient has pain and difficulty in rotating the arm and difficulty in movement. The nurse and the patient felt had an intrasupra splintus tear due to the injection being given in a tendon rather than the deltoid. At the time of the report, the outcome was unknown. The reporter reported that it believed to be mechanical injury on 20-OCT-2008. Additional information has been requested.
Slight swelling and redness after injection that went away. 8 days later,  a  nickel size redness and silver dollar size swelling/hardness with tenderness at the injection site suddenly came back. No other symptoms. By day 10, tenderness and swelling going away.
Headache, Myalgia, SOB, low oxygen levels, short winded walking, Narrative:
I had vaccination on 10/18/2022. On 11/24/2022 I was tachycardic for over 10 minutes. I got to over 171. I went to the emergency room. I was tested for COVID and flu. I was negative. I would lay down and my heartrate would go down but as soon as I sit up it goes back to the 140-160's range. I was referred to cardiology in 12/2022. In 01/2023 I was given additional medication and it didn't do anything. I was changed medication on 04/12/2023. I started to have rashes about this time as well.
p/vax pt became irritable & had sticky black stool & began vomiting;dx viral GE;taken to ER 6/20/99;abd x-ray revealed an ileus pattern versus obstruction;pt transferred to another facility where intuss confirmed by abd ultrasound;recovered
This spontaneous report as received from a physician via field representative refers to a patient in 60s (gender unknown). On an unknown date the patient was vaccinated with ZOSTAVAX (lot # and expiry date not specified), for the prevention of shingles. No concomitant medications are reported. On an unknown date after receiving ZOSTAVAX the patient developed a mild case of shingles. The patient sought medical attention. The outcome of the reported event was unknown. The causality was also unknown. No Product quality complaint (PQC) was involved. Additional information is not expected as the physician did not give permission to be contacted.
Torso hives, swollen/puffy face and feet, Vomiting. headache
Numbness in hands.  Numbness in left arm.  One week later: numbness on left side of face.  Neuropathy on left side of body, and right hand.  Intermittent paralysis of left side of face from eye to lip.
General low energy, rash on front of body, pain in throat/mouth.  Sudden symptoms, muscle pain.
Information has been received from a nurse, concerning a male who on sometime last week (approximately 18-AUG-2008) was vaccinated with ZOSTAVAX. There was no concomitant medication. The patient experienced generalized rash after vaccination with ZOSTAVAX. The patient sought medical attention, seen in office. There was no product quality complaint. Additional information has been requested.
mom called 17JUN96 stated pt had temp of 105 11OCT96;had sz 12OCT96 & took pt to ER test were run;MD couldn't find any cause for sz;MD felt might be from DTAP this incident was also reported to family MD per mom;14OCT96 had rash;
Pt had Covid vaccine on February 8th. Her daughter saw her on February 15th and noted right sided facial drooping. Pt noited her right eye had been tearing quite about for at least 2 days prior to the 15th.
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 73-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy Mango" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 27Oct2023 to 31Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357108 same patient, different drug/event;
Duration of diarrhea following first dose of vaccine on 16Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient called and asked about duration of diarrhea following first dose of vaccine on 16Jan2021.  Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.