chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Early on the morning of 11/9/2022, I felt like I was coming down with something, because I had a general malaise, achiness, and significant feeling of weakness. I felt so ill that I asked my wife to drive when we went somewhere; this is unusual for me, as I always drive. Also, things that weren't normally heavy felt heavier than usual, and I was exhausted after carrying them. I developed some nasal congestion. I also felt feverish and developed an extremely sore throat. I also had watery eyes. I took a home antigen test and got a strongly positive result. My wife bought various brands of throat lozenges, and they didn't help my sore throat. I had difficulty breathing that progressed. I couldn't even swallow water because of my sore throat. Things got so bad that we had to call the rescue squad, and I was transported to triage at the hospital. I was eventually put on an IV that night, and I was given SOLUMEDROL intravenously. I noticed that if I put my head all the way back, I could breathe better. My pulse oxygen level stayed at around 90, and I was on about 5-6 liters of oxygen. I continued to suck on ice chips. I underwent an EKG, and I saw on the heart monitor that I was in atrial fibrillation. For 24 hours, I could not have breakfast or lunch, because my throat was still so sore. I was in the ER for 31 hours before I was actually admitted to the hospital. While I was still in the ER, I was given an intravenous dose of remdesivir. When I was admitted to the hospital, I was breathing better and easier. I finally felt like it was safe to take a nap, because when I had difficulty breathing, I was afraid that I would die if I fell asleep. The hospitalist told me that I had COVID-19 pneumonia and that I would be in the hospital for at least a couple of days. I underwent an EKG every day while I was in the hospital, and I don't think I had atrial fibrillation again after 11/12/2022. For five days, I received intravenous doses of remdesivir and steroids. I ended up staying in the hospital for five days, and I was released on 11/14/2022. Starting on 11/12/2022 and 11/13/2022, I coughed for about 36 hours straight; I produced about five spit socks full of grayish phlegm. The doctors at the hospital told me that they weren't sure I would make it on account of my age and my blood pressure, but I was determined to survive. Six months have passed since then. When I now go walking with my wife, I still get winded more easily. I am working on building my strength back up, though. I would say that I'm now 80% better. I still get short of breath very quickly, but it is improving. I'm pushing myself to get in 100-120 strides a day at double time.
fever, headache, body ache. Fever started at 5 p.m. on Saturday, April 4 and last until Monday, April 5 at 5p.m. Fever spiked at 103.6 F on Saturday and then continued as a low grade fever of 99.9-100.5 for the reminder of the time listed. Headache and bodyache started on Saturday, April 4 in the evening. Headache went away by Sunday evening. Body aches started Saturday evening and continued through Monday, April 5 to 5 p.m. Experienced fatigue starting Saturday, April 4 at 5 p.m through today, Tuesday, April 6.
2 weeks after vaccine, itching on vaccine site. A case of rosacea as well.
Patient tested positive for covid-19 1 month after receiving 2nd dose of covid-19 vaccine.  Symptoms included fever, muscle aches, loss of taste and smell, headache, cough, nausea, and vomitting.
Patient came in today with redness and severe swelling at the site of injection. Area very sensitive to touch. She said it started when she woke up 1/23 after receiving the vaccination 1/22.  No oozing or pus present. Suggested she use an oral NSAID for swelling relief and ice the area. Told her to follow up with physician if symptoms do not resolve.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 22-SEP-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 28.9 degrees Fahrenheit (-1.72 degrees Celsius) for 48 hours to 28.9 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I'm not allergic to anything.  I don't get hives.  Ever since the booster shot, i started getting hives.  It is especially bad when I take hot showers.  The hives spread when I scratch it.  My skin plumps up.  I also experienced shortness of breath or difficulty breathing but only very very slightly for 1 day only.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 79-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 12-APR-2014, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), In 2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
reported total body itchiness, onset 1 hrs post vax lasted 2 hrs; mild h/a x 3 hrs; no rash, no swelling, no SOB; total resolution; not seen for evaluation;
2 weeks after the second dose, patient started having muscular pain on both sides of her back, light headaches and pressure on both sides of her ribs. Patient had constant dizziness sometimes characterized by a strong spinning sensation. Patient had the need to urinate frequently.  8 weeks later, on May 14th, 2020 the level of pain increased. Patient had stabbing pain around her ribs and upper abdomen. Patient felt inflammation around her upper abdomen. She went to urgent care that night. 2 days later on May 16th, patient went to the ER because pain was severe and her legs were very week. ER conducted a CT scan, blood test, X-ray; doctors did not find ?anything serious?. After this week patient suffered from insomnia. Patient felt organs were heavy causing discomfort and pain when she laid down. Patient had to sleep sitting up in her bed. Patient had muscle spasms around her abdomen.  On June, patient?s headaches were much stronger. Patient started taking muscle relaxants (cyclobenzaprine, 5 mg - 3 tablets per day) which helped decreasing the upper abdominal pain and headaches; Vitamin B (B-Complex 1 tablet per day) and B-12 (3,000 mcg 1 tablet per day). However, patient still had pain around her ribs.  At the end of July patient?s abdominal pain increased. Patient felt inflammation on her upper abdominal area. She could not stand up straight because of her pain in her abdomen.  Patient saw a Neurologist in late July who ordered an MRI of her thoracic spine; the results were normal. Patient saw a neurologist who specializes in chronic virus infections of the nervous system and virus latency in early August. Doctor prescribed Vitamin D, 2000 IU and Valacyclovir 1 g 3 times per day for 14 days in case the Varicella virus was active due to the vaccine. Doctor ordered blood tests of immune function and virology of varicella while patient was taking Valacyclovir. Tests results were normal.  In September, patient saw another neurologist who ordered another blood tests and MRI of her brain and cervical spine. Results were normal.  Patient started to recover in late September. In late December patient saw another Neurologist who specializes in Neuroimmunology. Doctor indicated that symptoms coincided with a condition called transverse myelitis. He indicated that MRIs might look normal with this condition. The way to identify an inflammation of the spinal cord would be through a lumbar puncture and test the spinal cord fluid. Patient was feeling better at that time and did not want to get tested.  Patient recovered by the end of December 9 months after the first symptoms started.
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This is a case of Expired Product Administered concerning a 73-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.; Sender's Comments: This is a case of Expired Product Administered concerning a 73-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
About 5-10 mm after immunizations were given (Hep A - Varicella - Meningococcal). Pt developed throat tingling sensation and dizziness, then collapsed. Mom note his face color was green > L. blue. Pt without AMS. Vital signs initially with low BP but with observation his BP recovered. BS was in the 70's. No systemic allergy reaction noted belief secondary to vasovagal response.
Patient came in during a flu shot clinic and stated he was getting the flu shot. After patient left staff realized he had gotten two flu shots and needed COVID vaccine instead. Patient had declined information sheet when he left the clinic. No reactions at this time.
1 1/2" x 1" rash @  site of inj w/itching & pain & knot;rash gone by 10/25/99 7AM;pain & itching still present;
Patient developed intense itching covering entire body within 30 minutes of injection. Patient consulted via text with physician from her office (works in pediatric office) and advised to take Benadryl as there was no rash, swelling, or shortness of breath. Within 30 minutes of Benadryl being taken patient experienced relief from the intense itching, however when it came time for a repeat dose of Benadryl patient was experiencing the intense itching again. This continued through the next morning. Patient is in fact still experiencing itching - however not as intense as last night. Patient continues to take Benadryl and it continues to provide relief - no other symptoms are presenting  at this time.
Patient received vaccine 5/2/21. Patient went home and noticed swelling, redness, bruising, burning, and numbness (to end of fingertips) in the injected arm. Reported severe dizziness and passed out. She also experienced increased heart rate/blood pressure. On 5/3/21, while experiencing the same symptoms, went to nearby medical facility (urgent care) where she was told that a nerve had been hit or bone had been hit. She was sent home with a heart monitor, in a sling, and was told to stay home from work for 2 days. Her symptoms continued through the day, continuing into 5/4/21. As of 6pm 5/4/21 she is going to go to an emergency room.
Information has been received from a physician concerning a 12-year-old male who on 12-JUN-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 08-OCT-2007, the patient was diagnosed with a "mild case of chickenpox". There were less than fifty pox and the child was experiencing a headache, sore throat, and fever. The patient sought medical attention via an office visit. On 12-OCT-2007, the patient recovered.  A product quality complaint was not involved. Additional information has been requested.
Within 5 minutes after receiving injection in the arm, I felt a heat wave coming over my body (started in my legs) & instant headache and sore arm.  After the 15 minute duration, I left the building and sat in my car for about 30 minutes  having the coldest setting of the A/C blowing in my face. I also felt my tongue swell up and felt a bit dizzy. Spoke to my family, informed them about my status. When I felt well enough to leave (within 45), I went home.  Symptoms did not come back. Arm remained sore for three days.
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX quadrivalent (unknown). In October 2013, within days of vaccination with FLUARIX quadrivalent, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX quadrivalent in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048964A-A1048967A.
pt recvd vax 24OCT95 & 12NOV95 pt devel 6 vesicular lesions;lesions were painful, but not pruritic;no further details were provided;
During observation after receiving 2nd dose of Moderna vaccine, client reported not being able to breathe. EMTs called. Vital signs taken. Client stated dizziness and some nausea. Client was offered water, monitored for an additional 15 minutes and stayed in the care of the EMTs. EMTs determined client stable and was able to go home of own volition. States she "feels better".
Patient was in the pharmacy around 11:30AM for Flublok, Boostrix, and Pfizer bivalent. After the vaccines, pharmacist advised patient to stay in the store for 15 minutes. A moment later, patient fainted at the shelf-checkout in the front near customer service. Manager on duty heard the fall and came over. Patient regained consciousness right away. A customer nearby claimed to be a nurse advised patient to be seated. Manager gave the patient some water and the patient claimed to feel fine. Pharmacist came to offer additional assistance, but patient refused and claimed to be okay. The patient looked very tired and pale, few minutes later patient left store and refused further assistance.
Shortness of breath; Fatigue; This is a spontaneous report received from a contactable physician, reporting for the patient. A non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within four weeks prior to the vaccination. On 15Mar2021 (2 days after vaccination), the patient experienced shortness of breath and fatigue. The patient had not received any treatment for the adverse events. The patient had doctor or other healthcare professional office/clinic visit as a result of the adverse events. The clinical outcome of events shortness of breath and fatigue were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient started feeling sick the next day. He had a sinus infection that was diagnosed 3 days later. After 10 days of antibiotics it was not improving. Now on second antibiotic and steroids. Patient also developed a rash on leg and arm.
Got first shot in 2019, forgot to get second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: The reporter reported that the patent forgot to receive the second dose of Shingrix vaccine. The reporter wanted to know if the patient needs to start the series over. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt recv vax on 11/20/98; on 11/25/98 pt exp hives-pain/itch ;pain of hand palms; red rash on face;swollen lip; achy joints; tired; tx=steroids, Prednisone, Benadryl
9:30 pm lungs started hurting & then felt numbness in left brain area that continued into my face near nose.  Subsided about 10:30 pm  Woke up with severe pain between shoulder blades & right hip area, slight headache.  Right eye felt like pebbles in it & couldn't hold it open til I got to bathroom to put in Alaway eye drops Extremely red & Left eye was irritated & put drops in as well.   4:30 pain was really bad & put Menthol linament on it, applied ice packs to shoulder blade. Took Tylenol on & off all day as pain persisted until Sunday.
heavy legs; Stroke; runny nose; a little temp; Not feeling himself; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LIMB DISCOMFORT (heavy legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation since 2017.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy legs) (seriousness criterion hospitalization) and FEELING ABNORMAL (Not feeling himself). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and BODY TEMPERATURE ABNORMAL (a little temp). The patient was hospitalized from 29-Jan-2021 to 02-Feb-2021 due to CEREBROVASCULAR ACCIDENT and LIMB DISCOMFORT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident and Rehabilitation therapy for Limb discomfort. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LIMB DISCOMFORT (heavy legs), RHINORRHOEA (runny nose), BODY TEMPERATURE ABNORMAL (a little temp) and FEELING ABNORMAL (Not feeling himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners which patient had reportedly been taking for approximately four years to treat atrial fibrillation.  Treatment included rehabilitation and learning how to ambulate with a walker.  Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.   This case was linked to MOD-2021-008992 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Case updated to serious, events added.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.