chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered at 12:06 pt moved to observation area for 15 minute observation. Pt. reports nausea and lightheadedness started after sitting in observation. pt stood up and reports feeling of lightheadedness; and nausea increased. Pt collapsed into supine position. Pt reports she attempted to lay head down but "went faster than she thought.: Pt was  BP Prone/supine 102/76 P 84 sitting BP: 116/95 P: 65 BP@13:08 128/94  P: 64
Extreme Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Extreme Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.  The patient's past medical history included Asthma (onset before therapy and controlled), Heart murmur (leaky valve onset before therapy and controlled) and Acid reflux (esophageal) (resolved from  taking Motrin). Previously administered products included for Product used for unknown indication: Motrin. Past adverse reactions to the above products included No adverse event with Motrin. Concurrent medical conditions included Hypertension (Controlled with medication. Had 5 years ago.).  On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. In 2021, the patient experienced FATIGUE (Extreme Fatigue). The patient was treated with PREDNISONE (oral) at a dose of as needed only. In 2021, FATIGUE (Extreme Fatigue) had resolved.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/70. On an unknown date, Blood test: Normal. On an unknown date, Colonoscopy: Gastrointestinal bleeding from motrin.. On an unknown date, Echocardiogram: good with strong heart beat.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FATIGUE (Extreme Fatigue) to be related.    Patient reported no break in therapy. When blood pressure in low, patient feels dizzy and nauseated. Patient had no missed doses of vaccine. Blood test was done for arthritis.  No concomitant medication information was reported. No treatment medication information was reported.  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.
pt recv vax 17MAY96 & 25MAY96 pt exp a rash on body, feet, & arms;described by the reporter as scattered red lesions not vesicular in nature & by the pt mom as looking like prickly heat;
Patient with COVID booster on 08/08/2022 who was diagnosed with COVID via PCR on 08/14/22 and admitted to hospital with COVID complications.  Provider d/c note:  "79-year-old female patient with past medical history of morbid obesity, hypertension, diabetes mellitus, elevated cholesterol, was recently admitted the hospital from 08/04 through 8/8 for left calcaneal wound, osteomyelitis, on IV Unasyn at nursing home through September 18 th   79 YO female presenting to the ED with sob. Past medical history as listed below. Patient reports 1-2 days of shortness of breath, cough, congestion, fevers.  She was recently admitted for left heel wound from 8/4-8/8.  She is currently receiving Unasyn through a PICC line.  She is living in a nursing facility.  Overnight they noticed that she was satting 70-80% on her home CPAP with 2 L. they noticed a temperature of a 101° there.  The EMS reported    Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  treated for acute hypoxic respiratory insufficiency from COVID pneumonia, on Decadron and remdesivi"
Patient received 0.5ml instead of 0.25ml of vaccine and was called on phone and denies any problems since vaccination. Letter was also sent to patient informing of dosage given
She had SHINGRIX 8/21/2018, the following day had significant blood pressure spikes BP 223/109, and dizziness. Seen at the emergency room, evaluated, including CT scan, EKG, and labs. Evaluation was negative. Blood pressure over the following two days is trending down.
Day 1: Mild hives appeared on face several hours after shot. Day 2: Hives worsened slightly and there were several more on upper body and face. Day 3: Stayed the same. Day 4: Extreme fatigue and napping. Hives started to clear. Day 5: Fatigue continued.  Day 6: Fatigue and napping continued. I got some mild chills during these days of fatigue, but never took my temperature. I basically felt like i had the flu. My hives were mostly clear by day 5. Day 7: Fatigue continued. Day 8: Exactly 1 week later, Thursday. Fatigue lessened. No naps. However, I began getting nerve pain in my right ear. Day 9: Fatigue still clearing. Ear pain continued to feel like nerve zingers; I also felt them a little bit in the back of my head on the right side. Day 10: Nerve pain continued. Woke up with a sore throat and drippy nose on left side. Took allergy medication (loratadine) in case it was allergies. Day 11: Nerve pain not as frequent, but sore throat worse. Felt like strep but only on left side. This is today. I will most likely get tested for covid on wednesday just in case i contracted it at the vaccination clinic.
On 26 Feb R eye became clouded.  By the 28th, I had lost all sight in R eye.  Suspected I had a torn retina, as I had in L eye several years earlier, I made an appointment on the 26th to see my optometrist.  I saw him on 3 March where he diagnosed that I had a more serious problem.  At that time some of my R eye sight had returned but I could only see the top line in the chart.  He made an appointment that day for me to see an ophthalmologist.  She checked me out.  I had a severely inflamed optic nerve in the R eye and my L eye optic nerve was inflamed but not to the extent of the Right one.  I was sent to get an echo cardiogram and a carotid artery ultrasound.  I was referred to a neurologist ophthalmologist but couldn't get in until March 12.  On March 10th I was told to go to the ER room for a workup prior to my 12 March appointment.  I got an MRI CAT scan, lots of blood work, etc.  I'm running out of time to finish this.
Before I went to bed at around 11:30pm the day of my shot (4/13), I took one extra strength tylenol as prevention. I woke up around 2:40am 4/14 trembling as if I was having a seizure (it did not feel like chills) and extreme aches. I took my temperature and was at 100.8. I took another extra strength tylenol and tried to calm down. At around 3:30 the trembling stopped and I was finally able to relax a bit. I fell back asleep around 5am and woke up at 9:00am with more extreme aches and pain. I switched to ibuprofen (400mg) and that worked way better. My fever was at 101.8 when I woke up. Around mid morning and afternoon I was feeling fine just a bit achy and fatigued and my fever broke to 99. I took a nap around 2pm and woke up feeling bad again with a fever of 100.6. I took another 400mg of ibuprofen and that got me through my class and the evening feeling okay. Before bed, I was feeling achy and fatigued yet again. I took 200mg of ibuprofen and went to bed just fine. I woke up at 4:30am 4/15 for my clinical feeling back to normal. I have been fine ever since.
pt recv vax 28OCT98 & in the morning of 29OCT98 devel bilat swelling of facial cheeks w/erythema, h/a & nausea;lt arm was sl ecchymotic @ the inj site;
seasonal influenza vaccine given at primary doctor's office at the left upper arm resulting in a localized reaction of swelling and erythema that improved with Orapred, Pepcid, Benadryl.
she got the hematoma in her right arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 11Feb2021 (Lot number: EM9809, Expiration Date: Jun2021) at the age of 64 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose Lot Number: EL3302), administration date: 21Jan2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: HAEMATOMA (non-serious) with onset 11Feb2021, outcome "recovered" (Feb2021), described as "she got the hematoma in her right arm".  Additional information: The only reaction she had in 11Feb2021 when she received the vaccine, was that she had a hematoma. She got the shot in her left shoulder and she got the hematoma in her right arm. Within 4 or 5 hours, she just looked down and had this very large hematoma on her forearm. It lasted a good 10 days, at least. The patient did not remember which location in her body she received the first dose.
Experiencing ulcers in my mouth. Yes. I have two bump on my right cheek, Inside and inside my right, It one only inside of my lip on the left side.; It was the very painful.; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), intramuscular, administered in Arm Left on 11Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ulcers in her mouth. yes. She have two bumps on her right cheek, inside and inside her right, it one only inside of her lip on the left side, it was very painful on an unspecified date. Outcome of events was not resolved.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Around two days later, I started noticing I was having sinus headaches and memory issues. I have extremely increased body aches; muscles aches. I don't know if it is just me or in relation to the vaccine or not.  Mood seems altered but I am in pain. Taking Tylenol to try to help with symptoms.
Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that happened parallel to erratic high blood pressure, 199/98. Chills, shakes, joints and muscle pain, headache, palpitations, night sweats, severe fatigue. From day 3 to day 17. Went to healthcare facility twice, and two doctor calls.
Discharge Provider: Private MD Primary Care Provider: Private, MD Admission Date: 7/27/2022 Discharge Date: 08/01/2022 PRESENTING PROBLEM: Lactic acidosis [E87.2]- Alcoholic ketoacidosis [E87.2]- Hypomagnesemia [E83.42]- Alcohol abuse [F10.10]- Microcytic anemia [D50.9]- Generalized weakness [R53.1]- Polysubstance abuse (HCC) [F19.10]- Typical atrial flutter (HCC) [I48.3]- COVID-19 virus infection [U07.1] HOSPITAL COURSE: Patient is a 53-year-old male with PMH significant for severe esophagitis (EGD 6/19 and 2/16), Mallory-Weiss tear in past, history of duodenal ulcer, chronic microcytic anemia, iron deficiency, chronic alcohol abuse, history of DVT/PE (02/2022), depression/anxiety and homelessness who presents to the ED for generalized malaise, cough and SOB. Found to be Covid positive. CXR is negative and SPO2 stable on RA. While in the ER he was noted to have transient a flutter/RVR with HR 140s, otherwise vitals within normal limits, labs consistent with anion gap metabolic acidosis with gap 25, bicarb 13, lactate 4.2. D-dimer elevated at 1100. He was also hypoglycemic at 55, elevated beta hydroxybutyrate 5.2 UA was negative overall but positive for ketones. Blood alcohol level at 0.045. He was started on IVF for alcoholic ketoacidosis and admitted to internal medicine service for supportive treatment. CTA thorax was obtained and revealed acute subsegmental pulmonary embolism in the left upper lobe, no evidence of right heart strain. He had PE/DVT and 02/2022. Was previously on Eliquis but was poorly compliant. During admission in June previous PE noted to have resolved but had residual small chronic DVT in posterior tibial vein. Hypercoagulable workup revealed--low protein C 62% and low AT III 49 %. Hematology recommended continued prophylactic dosing of Eliquis which the patient refused at discharge. Discussed with hematology again this admission who advised life long anticoagulation given recurrence. He was started back on Eliquis at starter dose. He had no further episodes of AFib/flutter in her heart rate remained stable. Echo obtained and was unremarkable. Acidosis quickly resolved with IV fluids and anion gap closed. IV fluids are stopped and he tolerated diet although notably has poor appetite. He had some mild hypokalemia and hypomagnesemia which were replaced. Patient continued to feel poorly due to COVID 19 symptoms but vitals remained hemodynamically stable on room air. He received 1 dose of remdesivir but declined further dosing because patient advocate had concerns about side effects.  He was otherwise treated with supportive care. Discharged was delayed due to homeless status until he completed 5 day isolation period, at which point he could be discharged back to local shelter. Patient was strongly advised to be compliant with Eliquis and follow up with PCP for refills of this medication. Patient in agreement with discharge plan and discharged in stable condition.
2/4/12 started hives all over body, temp 101. Injection site swollen, red, itchy. Continued through 2/6/12 seen by physician in administering clinic. Taken off work for 2/6/12. Cool compresses & to use BENADRYL. 2/7/12 follow up phone call.
Dizziness, headaches, fever, nausea, terrible pain in left arm and it hasn't gone away yet.  Could barely pick up the phone.
Sob started 3/18/2021 Admitted with dvt and pe 4/7/2021
pt recv vax 17OCT95&19FEB96 pt appeared to have broken out w/a case of chicken pox w/10 gen lesions;the reporting nurse stated there had been an epidemic of chickenpox that are going around the child's day care;
Progressive pain and disability in the following: knee to knee to hip, fingers to shoulders, to elbows, to feet with earaches, failing eye sight and tingling on skin surfaces. Also has finger numbness, muscle pain, head and neck pain. The annual follow-up states "all bones, joints, front teeth very painful. Large muscle cramp and painful disabling at an ever increasing pace disease."
Swelling and redness at injection site, high fever, extreme irritability, non-stop crying, diarrhea, vomiting, excessive gas, unable to sleep.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 17th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site rash and skin warm. On 18th June 2018, the patient experienced lethargy and pain. On an unknown date, the patient experienced product supply issue. In July 2018, the outcome of the injection site erythema, injection site pain, pain, injection site swelling and injection site rash were recovered/resolved. On an unknown date, the outcome of the lethargy and skin warm were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, lethargy, pain, injection site swelling, injection site rash and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left deltoid. The next day, after SHINGRIX injection the patient did have lethargy and was achy but lethargy passed within the first 24 hours. The patient stated that her arm was warm to touch. She had soreness at the injection site which developed within 48 hours of getting the vaccination. The area got bigger with swelling and a rash developed after the erythema. The entire episode took 3 to 4 weeks to completely resolve. The patient planned to obtain the second part of the SHINGRIX series despite the side effects, however, was unable to locate any providers who had the product in her area (product supply issue).
No other issues or concerns noted; Varivax had a temperature excursion and had been administered; This spontaneous report was received from an office manager, referring to a 4 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion was of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 15-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U008180, expiration date reported as 12-DEC-2023, for prophylaxis (strength, dose, route and frequency were not reported). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
received the expired fluzone dose with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old female patient to whom expired fluzone dose with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose of 0.5 ml (lot UJ776AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for immunization.  On 20-Oct-2022 the patient developed a non-serious received the expired fluzone dose with no reported adverse event (expired product administered) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: Not applicable.  Outcome: Unknown.    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 the 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.
* Headache as well as pain in the neck, shoulders, and back * Racing heartbeat and heart palpitations * Ongoing pain, swelling, stiffness in the hands and fingers, elbows, knees, ankles, and feet * Ongoing tiredness and fatigue
pt recv vax & 48hr p/vax pt exp lymph node swelling under arm 4 to 8 wk p/vax , exp pain in arm down to hand w/weakness;pt exp  progressively spreading weakness in arms down to hands;pt seen by specialist @ two hosp & dx advanced neuropathy
I got my vaccination in November and my Menstrual Cycle started a couple of days later and it lasted 3 weeks. It went on for a while and I contacted my doctor but he didn't give me anything.
pt recv vax OCT95 & devel redness, warmth, and/or soreness to the inj site;no tx necessary;pt recovered;
Post vax on approximately 08/14/2000, the patient developed shingles with patches on her chest, back and lower on the waist. The patient's rash lasted for a while and the area was still discolored. Unspecified medical attention was sought. Additional information has been requested.
Patient began to experience pins and needles in upper lip and left cheek within 15 minutes of vaccination.  Later that evening her chin, ears, and around her eyes developed hives and were very itchy.  She also developed swelling under both arms the following day.
heart palpitations; short of breath; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 19:30 (Lot number: EW0179) at the age of 20 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Batch/lot number: EW0161 , left arm), administration date: 26Apr2021, when the patient was 20 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 15May2021, outcome "unknown", described as "heart palpitations"; DYSPNOEA (non-serious) with onset 15May2021, outcome "recovering", described as "short of breath". Therapeutic measures were not taken as a result of palpitations, dyspnoea.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He states he received the Covid 19 vaccine because his mother was a doctor and she advised him to get the vaccine. If it wasn't for her telling him to get the vaccine he would not have gotten it. Patient got his second dose and it gave him side effects like heart palpitations and he was short of breath. When probing if the caller is still experiencing side effects he states when he exercises he feels like short of breath a little bit. When he does hard exercises he is still short of breath.  His side effects started about 25 minutes after he received the Covid 19 vaccine. He states he has no medical history and he does not take any medications. He does not do drugs and he does not smoke. He doesn't do anything. When probing for his date of birth he said first 1998, then 1999, and then 2000. He said he was 20 years old. This is discrepant but documented as provided by patient. He declines to provide the day and month. He did not have to see a doctor or go to the emergency room for treatment. No adverse events reported following prior vaccinations. No relevant tests reported.   No follow-up attempts are possible. No further information is expected.
Chills after 11 hours, chills and fever and body aching throughout the night, extreme tiredness, symptoms began to diminish after 26 hours post-vaccination.
Side effects post reception of latest Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects post reception of latest Moderna Covid vaccine) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects post reception of latest Moderna Covid vaccine). At the time of the report, IMMUNISATION REACTION (Side effects post reception of latest Moderna Covid vaccine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Live Non-significant Follow-up received contains reference number added.
COVID arm.  Swelling and redness at injection site. Just noticed it this evening post workout. No pain or itchiness.
Very heavy period the day after the vaccine  Very heavy nose bleed that lasted for more than 30 minutes and required an urgent care visit  High blood pressure (140/92) and heart rate