chrisvoncsefalvay/vaers-outcomes huggingface dataset:
early morning of 1FEB97 awoke w/fever & dry heaves;devel a sz described as whole body shaking w/eyes rolled back lasting about 30 seconds;several seconds of blank staring;fussy & sleepier than nl for about 1wk;seen for serous otitis 4FEB97;
3 days following vaccine patient called stating she was itchy all over her body and felt like bugs had bit her. She also stated she did not have a red warm rash on injection site but about 8" lower had a linear rash. Advised patient should go to urgent care or hospital to have it looked at.
Narrative: Pt seen the Vaccine Clinic. Pt states he receive two doses of Pfizer Covid-19 vaccine. Pt states after returning home he had itching and blisters appear on his arms. PT states this occurred after Series 1 and Series 2 of the Pfizer vaccine. PT has hx of CHF. Related reactions: fatigue, SOB. PT declined 3rd dose (booster) until he speaks with his Cardiologists.
Metal taste I mouth when eating or drinking, runny nose and congestion, shortness of breathe, severe fatigue, muscle and joint aches, swollen lymph nodes on armpit near site
Arms will fall asleep when laying on side. Tingling will continuebfor hours and hands even after change position. Arm made feel heavy for a bit. Also pins and needles feeling in feet, happens more when sitting. This has been going on for 3 months now. Gabapentin is not working. Took dicofenac for the first two weeks. The severity of the pain I was waking up with at night in my arms decreased but has never gone completely away.
Symptoms (Chest pain) within 3 minutes of admin took 2 hours for CP to resolve enough for patient to return to work.
Initial viral-like illness in the days after the vaccine.  On 10/25/2010, he developed horizontal diplopia, right eye ptosis, ophthalmoplegia and gait instability.  He was diagnosed with Miller-Fisher syndrome and is currently hospitalized.
I got the shot Saturday afternoon. My side effects started around 9:30 with chills?I just couldn?t get warm. I drifted off to sleep all right around 10:30, but by midnight, my legs were on fire like I?d just run a marathon. I?m pretty sure I had a fever because I was sweating and tossing and turning for what seemed like hours. By 4:00, I had a massive headache and felt like I was going to throw up. I took Advil and Zofran at 4 and went back to bed. Sunday I still battled headache, aches, and fatigue. The fatigue is what's still lingering yesterday and today.
From the time of the patient's injection he continued to experience pain for 2 months after no localized to the site of injection but to the joint L shoulder. Imaging completed showed findings of inflammation/synovitis and patient received a steroid injection to the subacromial bursa.
ARM INITAILLY SORE, PATIENT CALLED PHARMACY 3 DAYS LATER COMPLAINED 3INX3IN RED HOT SORE ARM IN INJECTION AREA NO OTHER COMPLAINTS.
I had a TIA (minor stroke) beginning symptoms on May 11, 2018. EMS responded to residence on May 12. Was admitted to Hospital via emergency room on May 12, 2018. Was tested with various tests (ekg, electrocariogram, MRI, CAT, etc..scans). Could find no other reasons or cause of TIA.  Symptoms were limited to speech aphasia, and confusion. These symptoms cleared up in 3-days time. All test results are on file with  Hospital in.  Neurologist was Dr. on Cone Hospital staff. Only diagnosis for cause was possibly XARELTO too low in system.
About a week after my shot I got into my hot tub and it caused inflammation throughout my entire body and it lasted for about 6 days. I had whelps and a rash all over my body. I also had really bad ringing in my ears for about 6 months.
I developed a very large, swollen lymph node under my left axillary.  I have never before had a swollen lymph node in either axillary regions of my arm. It was very painful, I could barely put my arm down because of the pressure of it pressing against the side of my body at rest. It has gotten better, there isn?t as much pain but it is still uncomfortable. The lymph node was/is palpable, and hurt upon touch and rest. The pain was an 7/10, but has now gone down to a 2/10. My arm is also still sore from the injection site, but it is not bad.
Information has been received from a physician concerning an 10 year old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (no lot# provided). Subsequently the patient developed chicken pox. Follow-up information received from a certified medical assistant who mentioned that all the patients that had been involved in the "school outbreak" had serological testing and none of the children had chicken pox: they all had only developed a rash. This is one of several reports received from the same source. Additional information has been requested.
received / first dose / about a year ago / was not informed about her second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). 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 details were provided as follows: The age at vaccination was not applicable to this report. Reporter is the patient. The patient inquired about getting a second dose of Shingrix vaccine. The patient received her first dose of Shingrix about a year ago, and due to system glitch at the pharmacy, patient was not informed about her second dose, which led to incomplete course of vaccination. The reporter did not have the following information from the first dose of Shingrix: lot no, expiration date, dose, and date of administration. The reporter gave a consent to follow-up with HCP.
Patient received first Covid-19 vaccine at 2:47. Patient reports within a minute or two she began to feel flushed and faint. Patient did not have syncopal episode. Patient was taken to separate room where she could lay down. Patient given crackers and water.  Vitals taken at 3:18 - BP 150/100, HR 82, SpO2 100%. Patient seen by Doctor. Vitals repeated at 3:30 - BP 155/95, HR 87, SpO2 100%, Temp 97.9F. Doctor reported patient feeling fatigued, but lightheadedness, flushing, and dizziness had resolved.   Doctor advised patient contact someone to take her home. Also advised to follow up with her PCP for elevated BP. If symptoms worsen or new symptoms arise, patient advised to go to ED for evaluation. Patient verbalized understanding.  BP checked once prior to patient leaving at 4:32 and was 142/100. Patient's sons came to clinic to drive her home.
dizziness; Nausea; fast heart rate; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old female patient received the first dose of bnt162b2 (lot number: EK9251), intramuscular in left arm on 04Jan2021 13:00 at single dose for covid-19 immunization.  Medical history included COVID-19. Concomitant medication included ethinylestradiol, norgestimate (MONO LINYAH). The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. The patient is not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient experienced dizziness, nausea, and fast heart rate on 05Jan2021. Since the vaccination, the patient has been tested for COVID-19 which included nasal swab test on 05Jan2021: negative. The outcome of the events was unknown. The events were reported as non-serious.
reporting that he felt feverish; had a blood blister in his mouth; he was really sweaty last night and early this morning; This is a spontaneous report from a contactable consumer.  The male consumer (patient) of an unspecified age received dose of (COMIRNATY, solution for injection, Batch/Lot Number: unknown) on an unspecified date via an unspecified route of administration at single dose for COVID-19 immunisation. The medical history and concomitant medication were not reported. Patient reported that on an unspecified date patient felt feverish, had a blood blister in his mouth, and he was really sweaty last night and early this morning. Patient was if there had been reports of a blood blister in the mouth. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After his most recent dose, he felt sluggish the next day.; The next morning (Sunday) he had no energy and couldn't get out of bed all day.; He has had no appetite and only ate a slice of toast yesterday; He was achy in his lower back, muscles, and kidneys; He had extreme nausea and vomited 5 times Saturday night; He had extreme nausea and vomited 5 times Saturday night; He was achy in his lower back, muscles, and kidneys; He was achy in his lower back, muscles, and kidneys; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.), BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.) and DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Oct-2023 at 6:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), MYALGIA (He was achy in his lower back, muscles, and kidneys), NAUSEA (He had extreme nausea and vomited 5 times Saturday night) and VOMITING (He had extreme nausea and vomited 5 times Saturday night). On 15-Oct-2023, the patient experienced ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.) and DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday). On an unknown date, the patient experienced SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.). At the time of the report, SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.), BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.), DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday), MYALGIA (He was achy in his lower back, muscles, and kidneys), NAUSEA (He had extreme nausea and vomited 5 times Saturday night) and VOMITING (He had extreme nausea and vomited 5 times Saturday night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2023, SARS-CoV-2 test: Negative.         Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745822 (E2B Linked Report). This case was linked to MOD-2023-745830 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745822:Wife Case
Soreness started within 1 hour after injection; fatigue grew. Soreness in left arm increased, much worse than typical flu shot or even tetanus. Low-grade fever developed 5-6 hours after injection ; only 1-2 degrees (99F) . 2nd day no ongoing fever or nausea but soreness in L arm affects reaching; and mild fatigue remains.
tingling finger & toes, ascending paralysis, quadriplegia, areflexia; Began 2 wks p/flu vax, progressed for 2 wks now recovering; dx GBS;
Information has been received from a physician and a female nurse concerning a female patient who on 09-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  On 09-AUG-2007 the patient developed, "alot of pain and numbness in the left arm which went all the down to the fingers".  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  Additional information has been requested.
severe diarrhea, nausea, stomach ache, indigestion, mild fever Treatment: Pepto Bismo, Mylanta, Imodium A-D and rest Outcome: pending
No additional AEs were reported; patient received an expired MMR II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 20-SEP-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter, once, lot # S029457 was confirmed to be valid, expiration date 19-SEP-2021, for prophylaxis (route and site of administration were not reported). No additional adverse event was provided.
Nausea first 2 days. Cold symptoms next 3 days, stuffy, runny, sneezing, cough.
still nauseated; achy; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In September 2020, unknown after receiving Shingrix, the patient experienced nausea and pain. On an unknown date, the outcome of the nausea and pain were unknown.   It was unknown if the reporter considered the nausea and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient asked how long side effect last for Shingrix.  It was second shot and the patient had every side effect listed. It was day three still nauseated and achy.
The patient was unintentionally given an extra dose of Pfizer COVID vaccine. At the time of the event the patient did not experience any adverse events or symptoms.
At eleven p.m. I developed a severe headache around the base of my skull.  Pain was so intense, I could feel it in the back of my throat. Took ibuprofen every 4 hours to lessen the headache. It finally dissipated by 2 pm the next day.
Patient received 0.25mL instead of the recommended 0.5mL for the bivalent booster. No adverse event, dosing error
After the first dose on August 26, 2021, I have become very tired throughout the day.    After the second dose on September 16, 2021, I have become even more tired throughout the day and have muscle and joint pain continuously, especially when I wake up in the morning.   I have also had intermittent headaches since my second dose.     This morning, , September 23, 2021, I feel as if I am coming down with a flu.  I have taken over the counter cold/flu/sinus tablets, but the symptoms continue with a headache, stiff neck, exhaustion, a shivers.    I have a normal temperature of 98 ,.
Myalgia, Diarrhea, Chills Narrative:  Other Relevant History:
Information has been received from a consumer concerning her 8-year-old daughter who was vaccinated with a dose of Varivax at the age of one year. Subsequently, the patient experienced varicella. No further information was available at the time of the report. Additional information has been requested.
Information has been received from a physician concerning a 41 day old male who on 19-APR-2006 was vaccinated with RECOMBIVAX HB and given a dose of Hepatitis B Immune Globulin at the time of birth. There was no concomitant medication. The physician indicated that the patient's mother is HBsAg-positive. On 22-MAY-2006, the patient received his 2nd dose of RECOMBIVAX HB (lot #651495/0505R) and his 3rd dose on 01-NOV-2006 (lot #651495/0505R). The physician reported that the patient did not seroconvert after receiving 3 doses of RECOMBIVAX HB. Additional information has been requested.
first dose of Shingrix on January 10th 2020 / second dose has not been administered ye; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 10th January 2020).   On an unknown date, the patient received 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 details were provided as follows: Age at vaccination was not applicable for this report. A patient had 1st dose of Shingrix on 10th January 2020 and the 2nd dose had not been administered yet which led to incomplete course of vaccination. The reporter did not consent to follow-up and follow up declined.  No lot number or expiration date provided.
1 week after the vaccination, I found that my arm was still very painful and my mobility had decreased.  I contacted my Dr in November to ask about the pain that continued in my arm at the injection spot and then made a visit on 12/8/16.  X-rays were taken and Meloxicam and physical Therapy were prescribed.
No additional AE.; HCP reported PROQUAD was administered to patients over the age of 13 years old.; This spontaneous report was received from a physician regarding an unknown number of patients of an unknown age and gender. Their medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates, the patients over the age of 13-year-old were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported.  Follow-up information has been received from a registered nurse on 08-MAR-2023.   The patient was a 37-year-old male patient. On 12-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot# W023866, expiration date: 24-JAN-2024, administered intramuscularly on the left arm. It was reported that the patient did no experience any adverse reaction and that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was just administered to an adult.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid, as patient identifiers were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009375:
Soreness and swelling in armpit of injection arm(L);  Same symptoms with vaccine in 2015, (R) arm.
20 minutes after giving his Pfizer COVID19 0.20 ml #1 dose injection they dad and Patient back stating that he was getting a rash on his face/neck.   Petechia noted on face/neck/ chest.  Was seen by Dr, and lab work completed, and stay and moitored for another hour.  No other symptoms were noted, cleared by Dr. and he was sent home with his father.  Father was informed to contact clinic is any other symptoms occurred .  He was not given any other vaccines within the past 30 days.  Did have his flu shot on 10/26/21.
death; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 5 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: death (death), outcome "fatal", described as "death". Additional information included: the 5-Year-old patient died four days after the Pfizer shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
2nd day, 2 red areas about the size of a dime 1/4 inch apart. 3rd day 1 large red oval area 4inches wide 2 inches tall swollen, firm to touch in and around the red area. Itching day 3rd and 4th day. Headaches 2nd and 3rd day. Tired 2nd, 3rd and 4th day. I'm preparing this report on the 4th day.
Seizure occurred 1/21/19. Lasted about 2 minutes. She was unresponsive and was rushed via ambulance to Hospital.
After receiving covid vaccine, and receiving patient education of Pfizer COVID vaccine pt states "I can't see." Nurse placed pt in supine position and provider was called to the exam room. Pt denies history of passing out with previous vaccines, denies LOC, loss of bowel/bladder and reports "I feel hot" and "I can't feel my hands and feet." Pt also reports she has not had anything to eat or drink prior to arrival to clinic. 1411 Vital signs: BP 107/69; HR 70; RR 20; pulse ox 99%. Upon provider exam mild pallor/diaphoresis noted, pt is awake alert and oriented to person/place/time/situation; No stridor, wheezing, sensation intact in all 4 extremities; pt has wrists and elbows in flexed position but able to straighten all upon request to place pulse ox and blood pressure cuff; 1415 BP 99/69; HR 102; RR 22; pulse ox 98%; Pt is continuing to report numbness bilat hands/feet and began to complain of nausea. EMS contacted. No hives, wheezing, stridor noted by provider, no emesis. Per provider sensations continue to be intact. 1423 VS BP 102/62 HR 67 pulse ox 99% pt remains awake alert and oriented x4; pt asked mom to contact her employer and call off work today. EMS arrives at 1430 and evaluates pt. After EMS evaluation, pt declined EMS transport states she feels better and just wants to go eat something. Pt reports symptoms resolved.
This spontaneous report as received from a licensed nurse practitioner refers to multiple unspecified patients of unknown age na gender. On 01-Oct-2014 the patients were vaccinated with RECOMBIVAX HB (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected ROCOMBIVAX HB. Reporter stated that she presumed she has administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursion of RECOMBIVAX HB was unknown. No product quality complaint was involved. This is one of the several cases received from the same reporter. Additional information has been requested.