chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was admitted with dyspnea and weakness, with recent diagnosis of Covid 19 infection.  She was started on steroid therapy, antibiotics and oxygen supplementation.  Patient continued to decline in clinical status despite medical therapy, requiring intubation and vasopressor support.  Family decided to withdraw care and proceed with comfort measures.
Became lightheaded, nauseated with a medicinal taste. Advised pharmacist. He told me I looked alert  and I could leave when I was ready. I left 10 min. later and drove home. I live alone. Laid down in bed for a short nap. Had severe headache. I did not/could not get up for 2 days. During those 2 days I had headache, chills and injection site was red hot, hard, and size of an apple. After 2 days the On the 15th of May I went to Pharmacy to get the SHINGRIX shot that you and I talked about. After the injection I began to feel a little light-headed and after 10 minutes of sitting in the pharmacy I was nauseated and tasted a medicinal taste. The pharmacist came over after 30 min. and said after the feeling subsided I could leave because I seemed alert. I was in bed for 2 days with severe headache, low grade fever, chills and the injection site was red hot, hard, and the size of an apple. After 2 days the headaches lessened, as well as the fever and chills. The injection site was the same and by the 5th day a painful rash broke out over all the redness and swelling. By day 7 there was some itching but everything began to stop. The injection site is still sensitive to touch. My question to you is: Should I go ahead and get the second vaccine in 2-4 months? I am asking this by mail since my next appt. with you is not until the fall.
Swelling and tenderness under L arm at approximately 10:00 PM with subsequent tenderness radiating to L breast, L deltoid area and L side of neck. Numb type feeling in L upper arm from shoulder to elbow. Ibuprofen 400mg taken every 4 hours since time of vaccination and warm compresses after symptoms began.
I woke up the next morning after getting my shot was huge cold sore on my right upper lip; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6203 and Expiry Date was unknown) via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that she woke up the next morning after getting vaccine shot, she had huge cold sore on her right upper lip. The patient usually when got a cold sore, she could feel it was coming on and stated "It was not boom and it was just there". The consumer was assuming, it was some type of side effects. The consumer asked if she take medicines for cold sores. Consumer was advised to consult her healthcare provider. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Excruciating right jaw pain 10 days after injection. Inflammation in right side gums and mouth. Fever. Cellulitis developed in neck on right side. Numbness on right side of lower lip/mouth. Right side forearm and right hand numbness and muscle weakness. Right leg stocking and foot also numb. ER and hospital admission November 15. Treated with Augmentin. Still experience muscle weakness and numbness in same areas 2.5 years later.
Shingles infection; A spontaneous report  was received from a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingles infection.   The patient's medical history was not provided. No Concomitant medications information was provided.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) in an unknown injection site for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced shingles infection (Herpes Zoster). No treatment information was provided.  The seriousness criterion for the event was medically significant .  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, shingles infection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
pt recvd vax;became cranky/irritable 4jan; 5jan fever of 102, inc to 104 by 7:30pm; fever cont thru 7jan95; no rash; vomited p/ feedings 5jan95;
Covid arm - warm itchy rash on my left around near the injection site. About 5 inches in length
Exactly one week later my arm got really red, swollen, sore and hot. That started on a thursday. Like as if I had gotten the vaccine that day not a week before. The next day my arm was sore and red, once again, as if I have just gotten the vaccine. Then friday my arm felt like I had gotten the vaccine the day before. Sore to move, hot, red and kinda itchy. It got so hot and uncomfortable I was icing it. Then Saturday my arm was sore but less red.  And by Sunday my arm was no longer red only slightly sore still. So it was quite literally the same reaction I had when I first got the vaccine but then again 1 week later.
A routine CBC, done 2 weeks after the Prevnar and HBV were given and showed miniature cells which were referred to a hematologist and prompted an evaluation for leukemia.
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 months old patient who was administered with a dose of IPOL lot P1A432M (Expiry date 20-Apr-2020) via unknown route in the right thigh lot P1A432M Expiry date 20-Apr-2020) via unknown route in unknown administration site and PEDIARIX on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due extra dose administered. It was reported that patient got a single dose of IPOL and PEDIARIX. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Day 4 woke up with bone,and muscle pain.  , Left leg edema started on 3-23-2021 and still has pitting edema present today and The Medical Doctor is aware of this.  Feels  Pressure on Left side of the head and pain in left eye  cheek bone >  Had  nose bleed on March 27th and March 23,2021.  .  Some dizziness noted 4-13-2021 and 4-14-2021.
Pt. was given: Menveo-Right Deltoid, HPV-Right Deltoid,  and last vaccine given TDaP-Left Deltoid by LPN. Per LPN pt. had syncope after last injection. Pt. was setting upright in chair and immediately after receiving the last vaccination Tdap, pt. became green/pale, eyes rolled back into his head, skin became sweaty and he loss consciousness for 10 seconds. Pt then came to and was aided in laying down on treatment table. Where he was assisted farther by RN and MD.  Parent stated that pt. had not eaten since the previous night so pt. was provided with a FiberOne brownie and electrolyte drink after which pt. stated he felt better.
Around 7PM, the same day of vaccine had, 102 fever, body aches and soreness at vaccination site.  It lasted about a day and a half.
9/24 PMHx of COPD, pneumonia, pulm HTN, Anxiety who presents for SOB w/ wheezing x 3 days. Diag. w/ Pneumonia upon assessment. 9/25 CT  suspicious for small pulmonary emboli. Examination of the lungs reveals numerous groundglass airspace opacities throughout the upper lobes and lower lobes bilaterally.  9/28  Lungs reduced  to auscultation bilaterally. Right lower lobe crackles. On CT There is interval worsening in aeration with development of bilateral infiltrates diffusely throughout both lungs. The pleural spaces remain clear.  10/4 patient currently requiring warmed high flow oxygen at 45L. Overnihgt desaturations into 10/5  10/6  pt desat to 62%, pt pale, tachypenic, tachycardic. Rapid response called to aid 10/6 Again RRT was called due to hypoxia Osat was in mid 80s%, pt was on high flow 10/6 She has been transferred to the ICU due to worsening respiratory status. Discussed plan for EGD tomorrow with patient and her daughter at the bedside.  10/6 Called to ICU patient showing signs of respiratory fatigue, requested to intubate patient. Patient oxygenated with ambu bag and mask with FiO2 100%. Intubation followed. 10/7 Central Line Placement - Right Internal Jugular 10/7 COIVD+ Result 10/7 Discussed with family poor prognosis, and clinical deterioration, will remain full code 10/8 CRITICAL CARE PROCEDURE NOTE - ARTERIAL CATHETER INSERTION 10/8 Septic shock with multiple organ failure, suspect ischemic bowel 10/8 Code blue called at 05:31 pm. On arrival to room, patient had achieved ROSC. Per nursing staff patient has been severely acidotic throughout the day with pH<7. Patient is on multiple pressors. Renal failure with hyperkalemia. There was suspicion for possible ischemic bowel however CT of abdomen could not be obtained as patient is too unstable. Patient had coded again while I was at rapid response. Per nurse staff ED doctor present for the code and pronounced patient
Pt. received Pfizer Covid shot #1 on 8/2/21 by unknown provider.  Presented to Medical hosp 8/22/21 for stroke like sx - stroke work up completed in patient - found to have R MCA occlusion likely cardioembolic.  Pt. discharged 8/24/21 - Pfizer Covid shot #2 given at Med hospital on day of discharge.  Pt. returned to Med hospital on 8/25/21 with new onset unresponsiveness/seizure like episode & worsening L sided weakness & deficits.  Admitted in patient for work up, &  found to have worsened Rt MCA diffusion restriction extending up to the posterior arterial watershed zone, likely cardio embolic.
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported . Treatment history was not reported .; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This is a spontaneous case, reported by other non-health professional and initially retrieved on 09-Jan-2019, concerning a 44-year-old, adult female patient. The patient did not have any medical history. The concomitant medication included unspecified vitamins for unknown indication. On 26-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF42809 (NDC 33332-0318-01) and expiry date: 30-Jun-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. On an unspecified date in 2018, reported as starting several days after receiving the vaccine, the patient felt pain at the injection site. Two days later after the injection site pain, the patient also had pain up to the neck, on the injection side and after that also up to the elbow. On 30-Oct-2018, 4 days after vaccination, the patient developed a lymph node and noticed the lymph node pumped up, that was then smaller, but the patient could still feel it a little bit swollen. Since 31-Oct-2018, 5 days after vaccination, the patient also started having breathing issues. The patient had several times and the worst time she went to the emergency room and was referred to two medical doctor (MD) specialists. Last time the patient had breathing issues was on holiday. As of now, the patient was being was followed-up by a doctor. On 06-Nov-2018, the patient had recovered from the event injection site pain (reported as for 1 week). The outcome of the events lymph node and breathing issues and were not recovered. The outcome of the events neck pain and pain in elbow was not reported. The reporter assessed the case as non-serious and causality of the events as related to the suspect vaccine (reported as adverse reactions). Reporter's Comments: A 44-year-old female patient experienced lymphadenopathy and breathing issues (dyspnoea), 4 days and 5 days after vaccination with AFLURIA QUAD respectively. Considering the plausible temporal relationship between vaccination to events onset and absence of alternate aetiologies, the events lymphadenopathy and dyspnoea were considered as related to suspect vaccine. The patient also experienced injection site pain with neck pain and pain in elbow later, unspecified period after vaccination. However, considering these reactions relating to injection site, the company assessed causality as related to suspect vaccine. The company assessed the case as serious (medically significant).
Patient is anxious of needles. After vaccine, patient was instructed to sit 15 minutes within a few minutes she began to vomit. We called paramedics her and she went home with guardian.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was reading at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
This spontaneous report was received from a Registered nurse regarding a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
wants to know if diarrhea is a side effect.; This is a spontaneous report from a contactable consumer (patient) to a Pfizer sponsored pro-gram. A female patient an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number and expiry date unknown), via an unknown route 01Mar2021 at single dose for COVID-19 immunization. On an unspecified date, the patient had diarrhea. The patient wants to know if diarrhea is a side effect. and why it was not listed as a side effect. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Prior to receiving the vaccine I had extremely mild tinnitus for about 10 years. It was barely noticeable and always at a constant level. Within 3 months of the second dose of the vaccine the tinnitus went from a 1 to a 10 on a scale of 1 to 10.  I could hear it over everything 24 hours a day. It was accompanied with severe hyperacusis which I had never experienced before. There was no other reason for this to occur but the vaccine. I have spent more than a year searching for the cause of this in hope that it could be reversed. I immediately went to see an ENT doctor in January 2022. They tried high dose steroids and allergy medicine which did not help. In December 2022 they had me get an MRI of the head and neck to rule out tumors and other ear related possibilities. No issues were discovered.  This tinnitus controls my entire life and I have ruled out everything else. I am convinced this vaccine caused this as the tinnitus grew worse not long after the second dose.
ON 2/10/2021- Resident with wife and he felt like he was going to pass out,  became silent and arms began to shake and then his dead went back and he began snoring. He was unresponsive for two minutes. While nurse was there to follow up he felt like he was going to pass out. He became silent again, but nurse kept talking to him. His legs began shaking uncontrollably. He remained alert with this episode.
This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV Dresden on 3rd October 2014. The subject's past medical history included pregnancy (2). The subject's estimated date of delivery was 1st July 2015. The subject received Flu Seasonal QIV Dresden at week 2 of the pregnancy and during the first trimester of pregnancy. On 3rd October 2014, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: The nurse reported that the patient received the flu vaccine in the past without any problems. The patient had no drug allergies. The nurse reported that her colleague/patient received the FLUARIX QUAD vaccine and did not know she was pregnant. Limited information was provided. The nurse wanted to remain anonymous.
Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of appetite, fatigue, abdominal pain, dizziness, near syncope, headache, insomnia,  arm soreness, tingling and numbness in my face and mouth about 10 hours after dose and lasting about 30 min, taking ibuprofen one tablet q6 hours for fever and pain. 26 hours dose symptoms are improving
Patient reports extreme pain for about a week after vaccine administration that has subsided but continued through day of this report.
Left upper extremity reveals 10 cm area of erythema, warmth and significant tenderness. Hard to the touch. Cephalexin 500 MG Cap, take one capsule by mouth four times daily for 10 days. No further reports from patient.
Swelling at injection site within hrs worsening over the next few days. Large baseball size lump at injection site. Sore arm, neck, and shoulder on side of injection. Body aches for 3 days.  Headache for 3 days.
Redness and swelling LUD.  Warm to touch.  Soreness X2days.  Mother states applied ice and gave TYLENOL for low-grade fever X1day.
Narrative: COVID infection following COVID vaccine series 12/17/2020, Pfizer, dose #1 01/07/2021, Pfizer, dose #2 10/06/2021 Pfizer, dose #3 08/30 pt cc: cognitively impaired exposure: unknown 08/30 COVID swab, result: detected 09/02 FIBRINOGEN 384 09/02 DDIMER 1.83 09/02 ESR 51 09/03 FIBRINOGEN 384 09/03 ESR 45 09/03 DDIMER 1.56 09/08 CK 56.0 09/08 CRP 3.109 09/08 FERRITIN 46.0 09/08 LACTIC ACID result: 0.79 09/08 COVID swab, result: detected 09/09 CTA PE impression: 1. No evidence for pulmonary embolism. 2. Bibasilar atelectasis and/ or consolidation with plugging of the lower lobe bronchi. 3. Debris in the distal trachea, suggesting aspiration. 3. Tracheomalacia. 5. Background of moderate to severe emphysema. 09/08 CXR Impression: Left lower lobe consolidation or atelectasis 09/09 SARS-COV-2 Variant Sequencing result: pending 09/09 ESR result: 66 09/09 Fibrinogen result: 459 09/09 DDIMER result: 1.44 09/09 PROCALCITONIN <0.05 09/10 ESR result: 35 09/10 Fibrinogen result: 541 09/10 DDIMER result: 1.17 09/10 PROCALCITONIN <0.05 9/11 ESR result: 70 09/11 Fibrinogen result: 555 09/1 DDIMER result: 1.38 09/12 SARS-COV-2 Variant Sequencing result: pending 09/12 ESR result: 72 09/12 Fibrinogen result: 459 09/12 DDIMER result: 1.56
headache/ light headedness BP:103/58 P-74 O2: 96%    #21 went home
Fever, Red area on Left leg where injection was given. Benadryl given for treatment.
patient received 2 vaccinations at pharmacy, Gardasil was administered first then the boostrix about 1 inch apart from the first in the same arm per patient request. After vaccination, patient was instructed to sit and take her time before continuing her shopping trip. A few minutes after her vaccine she tried to get up and asked to continue to sit. Patient was encouraged to take all the time she needed. She said she felt dizzy, pharmacist on duty offered water. After about 20 minutes and checking on the patient at 5 minute intervals she said she was not as dizzy but her heart started to feel like it was "beating really fast" and chest started to "feel heavy". At this time the pharmacist offered to call emergency services so she may be assessed appropriately. Patient declined. After about another 5 minutes patient was still sitting so pharmacist offered to call emergency services again. At this time she accepted, emergency was called and medics were dispatched. Upon their arrival medics checked patients vitals. Blood pressure, heart rate, oxygen saturation, heart and lung sounds. All tests reported within normal limits. patient's breathing become more normal. Per medic everything was normal and patient was given option to be transported to hospital but refused. Medics cleared patient. Patient said she was feeling better and ok to go.
developed swelling and pain (rated 8/10 pain with pressure only) on his right armpit/side yesterday following the booster vaccine. He said that the pain and swelling has improved today (rates 1/10 pain with pressure only). He denied observing any discoloration on the skin and not hot to the touch.