chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Progressive muscle soreness; Aching joints focused primarily in hips and hands; Extreme fatigue; Difficult to keep eyes open; Joint discomfort; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 07Apr2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included Lyme disease, the patient reported that the Lyme disease was was diagnosed with approximately 6 years ago and was identified by a tick and bullseye rash. It was treated with antibiotics within 12 hours of finding the rash. The patient reported that the recovery was slow, over two months. The patient had a known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) from an unknown date and for an unspecified indication and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Apr2021 at 17:00, the patient experienced progressive muscle soreness including aching joints focused primarily in hips and hands. The patient also experienced extreme fatigue where it was difficult to kept eyes open during the day "peaking on day 2 and lasting into the fifth day". The patient reported that the fatigue and joint discomfort presented exactly like the lyme disease which was diagnosed 6 years ago. The patient reported that this time the joint pain lasted almost five days. When the patient woke up in the morning after the fifth night, there was no more joint discomfort. The fatigue also subsided after the fourth night. The patient reported that the muscles were still a little sore 7 days after. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events progressive muscle soreness was resolved with sequelae on an unknown date in Apr2021. The clinical outcome of the event fatigue was resolved with sequelae on 12Apr2021, after a duration of 4 days and the events aching joints, difficult to kept eyes open during the day and joint discomfort were resolved with sequelae on 13Apr2021, after a duration of 5 days.  No follow-up attempts are needed. No further information is expected.
Severe chills, fever, constricted throat, difficulty breathing, sleeplessness, muscle and body aches
Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014 at GPV. Child received 0.25 ml dose of FLUZONE instead of 0.5 ml. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 4) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Started with aches, pain and headache on 1/14 pm.  By 1/15 am temperature had spiked to 106 but was responsive to acetaminophen and remained high until 1/17 am.  patient is continuing to experience aches and pain still 1/18.  Face was swollen and red until 1-17 pm.  Lymph nodes in neck, collar bone and armpit on right side were swollen and sore.  About 3 inches below actual injection site an area 1x2 inches is red and hot to touch still on 1/18
Increased redness, swelling, itching, site tender to touch. Site right deltoid. lasting 2 days. Treatment medication prescribed, Diphenhydramine Hcl 25mg as needed every 6 to 8 hours. Ice pack applied.
3/24/21 Fever and chills for most of the day. 3/25/21 Hands swollen, itchy started around 5 pm. 3/26/21 Thighs, Knees, Lower back, legs ,basically the whole lower body was swollen,  decent size blister developed on the left foot. 3/27/21 Symptoms are still the same as the day before
Patient return approximately 45 minutes post immunization with extremities pruritic urticaria diffusely over entire body with no localization at sites of immunization.  Decadron and Zyrtec.  Administered with EPI in reserve if resp symptoms presented.  Patient improved approximately 15 minutes after interjection.
9/5 left arm swollen and warm to touch. 9/4 area was itchy and swollen. May use loratadine and BENADRYL at bedtime.
The pt received a flu vaccine on 10/17/01. She had no problems until around Thanksgiving, at which time, she was dx'd with pneumonia and bronchitis. Shortly after this, she began experiencing a feeling of numbness in her feet, hips, arms, face and mouth. She told her doctor about these symptoms and was hospitalized in order to figure out what was going on. Her doctor could not find anything wrong. Even though she was discharged from the hospital, she continued to have problems. At this time, the pt's daughter took her to see another doctor and according to her daughter, the dx was confirmed as Guillain-Barre after obtaining the results of a spinal tap. The pt is currently recovering in the home of her daughter.
devel itching on feet then both arms but not @ inj site & by morning of 4NOV calves itched;redness @ site scratched;will consult w/PMD regarding rxn & med taking;
On 3/10/2023, I had a sore throat that lasted all day, which is very unusual for me. On 3/11/2023, I woke up feeling like I had the worst cold in my entire life. I had fatigue, muscle soreness, a headache, sore throat, sinus pressure, chest congestion, and chest cough (nonproductive). I took some OTC medicines, such as the generic version of DayQuil and Cepacol drops. They maybe helped a little, but not much. I kept coughing, and I was miserable. On 3/13/2023, I took a home antigen test and got a positive result. The symptoms continued for the next three days. On 3/17/2023, I had a telehealth appointment with a doctor. I felt a little bit better then, but not much. By that day, I had a severe dry cough. He prescribed an albuterol inhaler and benzonatate for the cough. He also prescribed an aerochamber to use with the albuterol inhaler. I honestly don't think that the medications helped. Since that day, my symptoms seem to have operated like a jagged line on a graph. Some days are better or worse than others. At the time of this writing, I'm mostly fine. However, I still have a dry cough and a lack of lung capacity. I also experience upper respiratory pain when I exercise heavily. I would also like to add that sometime between 3/17/2023 and 3/31/2023, my cough became productive. The productive cough lasted for about two weeks. I currently still have a dry cough, though.
I have developed continuous tinnitus in both ears. It began after the second injection and has never stopped.
Approximately 30 to 45 minutes after the vaccination I started to feel somewhat jittery and my left hand and into wrist became numb and tingly (pins and needles). Then my right hand started to feel the same way. My face started to itch some and my tongue felt tingly also. I took 25mg of diphenhydramine and waited to see if symptoms subsided. The itchiness in my face and the tingling in my tongue went away in about 30 minutes however the jitteriness and the symptoms in my hands remained. The only symptom at the injection site was slight pain and warm to touch. I was at the ER approximately 2.5 hours and slept while waiting on the blood lab work to come back. When I woke the jittery feeling had subsided however the tingling in my hands remained. I was discharged and the tingling in my hands was gone the next morning when I woke.
Patient came in for a COVID vaccine, after confirming with the immunization website it appeared that she needed her 2nd dose in the series. I prepared and administered that dose. Patient waiting for the standard 15 min with no reactions and left. When charting the vaccine I became aware that the patient already had received their 2nd Dose and was given a 3rd dose (or booster).
SEVERE PAIN IN LEFT ARM X 1 WEEK NOT RELIEVED BY OTC MEDICATIONS, UNABLE TO MOVE ARM X FIRST 2 DAYS,; MILD PAIN IN LEFT ARM ON THE 2ND WEEK FEVER OF 100.7 DEGREES F 15 HOURS AFTER VACCINATION. FEVER DURATION OF 12 HOURS AND WAS ACCOMPAINED BY FATIGUE AND MILD BODY ACHES.
Patient c/o tongue feeling weird after shot c/o nausea 1/2-10 after shot. Also c/o body aches rest of day. About 7 hrs after she received the shot, she had tongue swelling. Parents gave BENADRYL & swelling resolved. No resp distress/no difficulty swallowing.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.23.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 2 PM and 3 PM the temperature was 32,32,32,35 and 35 respectively. total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
pt recvd vax in 1989 following vax pt exp redness & induration @ inj site;reporter expressed a concern about lot# involved in the report;f/u indicated pt had erythematous rxn which appeared to be cellulitis;
10:30pm to midnight of feb 1st- chills, fever- extremely high- didn?t get out of bed to take temperature,  extreme pain under left armpit, nausea  Fevers up to 101.5  nausea, loss of appetite, headache until February 4th. February 5th- dehydration, tachycardia, shortness of breath- lasting entire day. Better by February 6th
mom phoned 830AM 13OCt98 said pt had broken out w/chickenpox also another sibling had broke out p/another sibling that did not have vaccine broke out w/chicken pox;rash was in hot spots & itching;
6 months p/receiving 3rd dose of Hep B vax devel stiffness in knees & joints & burning traveling to the foot;
Increased shortness of breath that started 1-2 days after receiving second dose.  Patient was on 4  Liters O2 prior to vaccination and prescriber (PCP) increased to 6 Liters to alleviate some SOB.  Patient has an appt with her pulmonologist on 2/10/22.
n/v, severe h/a, muscle aches & inj site discomfort;tx @ ER for s/s;pt recovered;
ACUTE PULMONARY EMBOLISM 11/7/2022 - RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
After injection, patient stood up and we noticed he was falling. We caught him, laid him on the floor and called 911. His blood pressure was 75/33 and heart rate was 57. Emergency crew took him to the hospital. I called his mom in he evening and she said he was fine, he got nervous during vaccination
Pt R hand and foot started swelling 4/20/2021, 2 days after Pfizer shot, on 4/18. Pt admitted to Hospital 4/23-4/25/2021. Pt was diagnosed with cellulitis and treated with IV antibiotics. Pt also treated for exacerbation of CHF and COPD. Pt re-hospitalized 5/7-5/12/21 for COPD and CHF exacerbation, a-fib with RVR, acute respiratory failure with hypoxia, and gout of R wrist Pt went to STR from 5/12-5/18/2021
Info has been received from a physician concerning a 24 month old male pt who in approx. September 2004, at 12 months of age, was vaccinated, SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. "This week", on approx. 9/21/05, the pt experienced breakthrough varicella and came to the office. The child had a few lesions and no fever. It was a mild case and no treatment was given. At the time of the report, the pt was recovering. The pt's twin sister also developed breakthrough varicella after vaccination with varicella virus vaccine live. Additional info has been requested.
One Tuesday, March 12, I began to experience dizziness when I got up from a sitting position. I incorrectly reported this as vertigo. Later that day, around 5pm I set out on a 10 minute walk to the bus stop for dinner. I began to feel pronounced muscle weakness in my legs and had to sit down and rest twice in 10 minutes, at the bus stop I settled into a squatting position to wait for the bus. When I tried to get up I blacked out completely. When I came to after perhaps a minute I was completely alert but had numerous cuts and abrasion (all minor) on my hands and face. Witness called for an ambulance to the ER at Heart. There I was told that all my lab results were good and I could go home. My final diagnosis, based on doctor's evaluation and the information provided by the CDC, was that the incident was caused primarily by a bad reaction to the shingirx vaccine aggravated by dehydration. Note that this took place four days after the shot, not minutes or hours as your warning indicated. Future warning given with the shot should include this possibilities so people can maintain reaction caution for several days.
Pt. got a flu shot at the school clinic. Went back to teach classes and felt funny. Came back to clinic BP elevated pulse elevated - red face & neck. BENADRYL adm. IM per nurse. Watched her x 15 min color back to normal BP coming down & pt went back to class to teach.
Cold; Headache; Soreness at injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness at injection site) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy since an unknown date. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness at injection site) and FATIGUE (Tired). At the time of the report, NASOPHARYNGITIS (Cold), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness at injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Slightly elevated heart rate - most of that afternoon through early morning  Slightly elevated blood pressure - most of that afternoon through early morning  Palpitations at night - when I went to bed that's when I noticed it up until 1:30'ish in the morning  I took one (1) 500 mg tylenol at around 1:00 am and felt a bit better; that was it
Pt states that after 2nd Anthrax; he experienced flu-like symptoms for about 5 days. Pt states that after 3rd Anthrax shot; he experienced severe headaches, muscle aches and dizziness. Pt states that it was very difficult to move.
Patient received expired vaccine. Pfizer recommend revaccination. Patient was contacted to schedule an appointment. Appointment was scheduled.
13OCT93 fussy immed p/inject, low grade fever in PM; 14OCT93 diaphoretic 6-7x; vomited 1x called hosp; called poison control; called ask-a-nurse on vax literature; fever 103; 20OCT93 sore in roof of mouth;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who on an unknown date was vaccinated with ZOSTAVAX (dose, lot # and route not provided). The pharmacist reported that an unspecified patient received an expired dose of ZOSTAVAX a couple of months ago. No adverse effects reported. Outcome of expired drug administered was unknown. No further information was provided. Additional information is not expected, because can't contact the pharmacist.
chills; feeling crappy; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included headache, sinus congestion, rhinorrhea and influenza like illness.   On 9th May 2019, the patient received the 2nd dose of Shingrix. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced chills. In May 2019, the patient experienced feeling bad. On an unknown date, the outcome of the chills and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the chills and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient had been worked out in the yard and the pollen around the air and given some issues with headaches and sinus was being stuffy and runny and just feeling like the flu. The patient experienced extreme chills last night of reporting and it could be combination of the weather and the shingles and the patient felt pretty crappy.
Headache fatigue Narrative: vaccine date 12/28. On 12/30 in the afternoon developed severe headache, fatigue.
rash on her arm; hot; itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash on her arm), INJECTION SITE WARMTH (hot) and INJECTION SITE PRURITUS (itchy) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash on her arm), INJECTION SITE WARMTH (hot) and INJECTION SITE PRURITUS (itchy). At the time of the report, INJECTION SITE RASH (rash on her arm), INJECTION SITE WARMTH (hot) and INJECTION SITE PRURITUS (itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Relates he became "dizzy" early the morning after his shot.  Relates his B/P was 95/50.  Reports he drove himself to the ER. Relates he felt "sick" for 3 days with dizziness after shot
Pt started feeling achy all over, sore, fatigued in 24 hours after her second dose. It progressively worsened over the next  month and a half.  Labs showed this week she is now positive for lupus.
Patient had a bruise and slight bleeding at the injection site.   Applied pressure and cotton ball to stop bleeding. Parent was not concerned about bruise, but I recommended cold compress/ice to the parent, and an analgesic if needed.
33 weeks pregnant. Due October 6, 2016. Healthy pregnancy. Ultrasound on 8/20/2016 at Prenatal visions showed perfectly healthy baby, placenta and fluid levels. Went into pre-term labor exactly 24 hours after vaccine. Contractions continued every 6-8 minutes for 7 days before delivering a premature baby.
Skin reactions with heat/pain swelling>12 cm on left arm on day 3 after immunization.
Rash on right abdomen, breast, side.  Itchy.  Still present after about 36 hours onset.
Patient developed bilateral leg weakness and dizziness 3-4 hrs after immunization. Returned to my office on 10/27/10 and could not walk without assistance. Was admitted to hosp. for workup. Transferred for pediatric care to another hospital. Entire workup negative. Diagnosis of bilateral leg weakness. F/U visit on 11/1/10- patient improving but has to use cane to ambulate.
Swollen glands around neck, breast and armpit area where injection was adminstered. The area was very tender.
03/10/2021 - @ 4.20 pm Vaccination Moderna 03/10/2021    @  9.00PM Fatigue 03/11/2021     @ 6.00 am Fever with Chills took Tyelanol at 10 am 03/11/2021     @ 1.00 pm Fever with Chills took Tyelanol at 1 pm 03/11/2021     @ 6.00 pm Fever with Chills took Tyelanol at 6.30 pm 03/12/2021  NO FEVER NO SYMPTOMS
24 hrs of vertigo severe nausea headache and tired. No appetite and did have light fever
Patient was at clinic for WCC given 3 vaccines ( HPV, MCV, Tdap). Stable/normal during exam. Provider left room after exam, MA administered 3 vaccines. Within 1( one) minute pt described headache, clutched sides of his head, closed his eyes and became stiff while collapsing. MA called provider who came in from room next door. Patient was tonic in all limbs, neck and jaw. Eyes open. Whole tonic state lasted approximately 30-40 seconds. Patient body relaxed, he appeared confused, then anxious/started crying/ trying to run from room. We convinced patient him to sit, took vitals. Pt remained stable until EMS arrived approximately 2-3 minutes post end of seizure. Pt reported severe headache, then no memory, then confusion. Denies incontinence during episode. Had mild-moderate headache after episode. Reports fall yesterday with no head injury or loss of consciousness. Never had previous seizure per mom. Pt transferred to ER for evaluation via ambulance.
Patient presented to the hospital on 11/1/22 for failure to thrive due to small cell lung cancer with mets. He tested positive for COVID on 11/3/22. He improved and was discharged from the hospital on 11/8/22.