chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced short term pain in upper arm around injection site - soreness lasted about 2 weeks. I started to become more easily fatigued to the point of needing daily naps by November. I wake up fatigued. I can usually make a meal, eat, feed my cats and then am ready to sit without energy to do much for an hour or more or even ready to take a nap which can last between 2-5 hrs. Cannot find the energy to shower everyday sometimes, much less actually get around to taking care of basic house chores like mopping, dishes, or laundry.  Brain fog - I forget what I am trying to do all the time and have to ask myself out loud or sing silly songs about the task so I remember what I am on my way to do. All appointments get alarms set or I will never remember them. Always using lists to put down details of simple tasks. Cannot read a recipe to cook just once - I must look at it 20+ times for a meal that should take 30 to 40 minutes to cook because I cannot hold the directions in my head.   I am currently under medical advisement not to drive more than 45minutes to an hour due to micro naps.  I have been applying for part time work (out of work since temp job in May 2021) but I am not sure how I will work once I land a job when I am so tired and forgetful at all times.
Patient presented to the ED and was then hospitalized within 6 weeks of receiving COVID 19 vaccination.
Erythema, edema, TTP, warmth, streaking from immunization to left axillary.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sodium pentothal).  On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-313106 (Patient Link).
GENERALIZED ITCHINESS AND C/O THROAT FILLIING A BIT TIGHT. REDNESS AT TRUNK/LEGS/BREAST.
Presented to ED w/pneumonia; dx as COVID-19 pna; tx w/abx; resp failure required intubation; peg placed d/t malnutrition; dc'd home w/HHC for O2 & peg tube care
Information has been received through the Merck pregnancy registry through an 18 year old female consumer who on 21-NOV-2007 was vaccinated intramuscularly with her first dose of Gardasil.  There was no concomitant medication.  Subsequently, the patient was determined to be 4 months pregnant (not further specified) (LMP approximately 15-AUG-2007).  The patient sought unspecified medical attention.  Follow-up information was received.  Concomitant therapy included prenatal vitamins ongoing for 1 tablet daily.  On an unspecified date the patient had an ultrasound and the results were twins 15 weeks.  A MSAFP Quad screen was 1.85 and was within normal limits.  In December 2007, diagnostic testing revealed that the patient had trichomoniasis and gonorrhea and was treated with FLAGYL and other unspecified therapy.  On 11-DEC-2007, the patient had heavy vaginal discharge.  The patient's LMP was 15-AUG-2007 and the estimated date of delivery is 21-MAY-2008.  Additional information has been requested. Follow-up information was received from the physician's office. On 08-MAR-2008 the patient delivered normal twin girls. Twin A was 3 lbs 5 oz and 32.2 weeks from LMP. The Apgar score was 9/9. Twin A also had routine prenatal labs "frequent US". Twin B was 3 lbs 13 oz and 32.2 weeks from LMP. The Apgar score was 8/9. Twin B was a preterm delivery and had premature rupture membranes. Twin B had decorded growth. Twin B also had routine prenatal labs "frequent US." The patient also had concomitant drug which included Celestone injections and "PROCARDIA" 10mg every 4 hours for pre-term labor. Additional information is not expected.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Within 5 minutes of receiving the vaccine, patient admitted feeling lightheaded.  He immediately became unresponsive and his body went stiff.  He was carefully lowered to the floor, still stiff with ragged breathing.  Patient was given an Epipen which brought him back to responsiveness.  Patient was able to answer questions following Epi and admitted to being scared.  Paramedics were called and patient was taken to  hospital for further treatment.
Immunization: COVID-19 PFizer-BioNtech 12yrs-adult, external - Pfizer vaccine was administered outside of Facility- reported by patient  J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/29/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
1/18/21 Fatigue, HA, congestion.  1/18/21 Tested positive for Covid
I received my first Moderna booster for COVID-19 on 12/04/2021. In the early morning of 9/17/2022, I had a fever of about 100 degrees. I then took a PCR test and got a positive result. I was abroad at the time, so I went to a website that provides medical guidance to travelers. The doctor I spoke to advised me to treat my symptoms with paracetamol. I took the paracetamol regularly from then on. Whenever I took it, my fever was reduced to about 98 degrees. However, whenever the medicine wore off, the fever would reach about 99 again. This pattern lasted for about 4 days before I stopped getting the fevers. Around 9/21/2022, I started developing fatigue and shortness of breath. The fatigue and shortness of breath lasted until around 9/21/2022. I tested myself regularly with antigen tests during my illness and had a positive result every day until 9/24/2022, which is when I finally got a negative result. On 9/29/2022, I took a PCR test and got a negative result. I didn't feel fully recovered until 10/3/2022, because I still have residual fatigue.
This case was reported by a pharmacist via call center representative and described the occurrence of feels awful in a 76-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 13th April 2018, the patient received SHINGRIX .5 ml. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced feels awful, pain in arm and exhaustion. On an unknown date, the outcome of the feels awful, pain in arm and exhaustion were recovered/resolved. It was unknown if the reporter considered the feels awful, pain in arm and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. After receiving SHINGRIX, the patient felt terrible, exhausted with an extremely sore arm which fully resolved after a few days.
A pharmacist reported that a 31 year old male received the fourth dose of hepatitis B vaccine recombinant on 5/18/04. The pharmacist provided the lot numbers of the most recent two doses of Engerix B; however, the pharmacist did not specify which one was administered on 5/18/04. The lot numbers provided were ENG5595A6 (expiration date 9/15/05) and ENG5582C6. Concurrent medications were not reported. Medical history significant for hemodialysis with catheter. Three days later, on 5/21/04 he developed fever and headache and was hospitalized. Blood culture was positive for Staphylococcus aureus. At time of reporting the events were unresolved. The pharmacist stated that the infection may be related to vaccination with Engerix-B or may be related to the patient's catheter.
Lump in throat, chills, fever, temperature-relieved by TYLENOL. Symptoms dissipated overnight.
Dizziness, extreme fatigue, body aches, nausea, diarrhea, rash/itchiness (ALL over)
Patient received vaccination at 12:10. At 12:25, patient complained of tongue thickness. EMS called. Difficulty breathing. Developed seizures. Epinephrine 0.3 administered. Seizures continued on/off for approximately 1234. Tongue swelling did improve. Transferred to hospital setting via EMS at 1245.
Breakthrough case admission after 3 vaccines Pfizer 3/2/21 lot# EN6200 ; Pfizer 3/3/21 lo# EN6208 ; Pfizer 12/16/21 Lot# FD0809
This spontaneous report as received from a nurse refers to an unspecified patient. On 05-AUG-2011 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route unspecified). On 10-JUL-2014, the was vaccinated with the second dose of GARDASIL (lot #, expiration date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Headache, Arthralgia, Fever, chills, itchiness Narrative:  Itchiness, fever, arthralgia, headache, chills
Headaches, back aches, lethargic, tiredness, arm pain, slight nauseousness, lack of appetite (about 40 hours with side effects)
Pt. received vaccination of FLUARIX; injection started to swell, asked pt to wait 15 mins; gave pt diphenhydramine 25mg and asked to wait 30 mins. Pain at site and swelling; I then went to Dr. explained what had occurred; schedule pt for a visit and Dr. identified hematoma.
patient is 13 and was given MMRV instead of separate MMR and varicella vaccines
Lasted about 24 hours, fever - 100.8, chills, body aches - felt like 24 hour flu.
Patient had severe itching, redness at site, Redness of both arms, hands, neck and face. Hives present.  C/o of mild nausea and dizziness.  Was placed supine on exam table and had mild SOB. Was given epinephrine pen 0.3mg/ 911 called due to sob. Paramedics evaluated, pt declined going to ER. Denied any further SOB. No acute distress. Took OTC Benadryl 50mg. Kept on site for  20 minutes. Parents present and driving. Left in stable condition.
Pain at the BL axilla and numbness and tinging at hands. Began immediately following the injection and worsened in subsequent weeks.
Urticaria began within a few minutes after vax given. PO Benadryl x 1 resolution of hives within ten minutes. No evidence of respiratory compromise/symptoms. No epinephrine given.
Had severe upper back pain on left side. Was not even able to turn other side during sleep or not even able to walk still. Took Tylenol, kept ice, put ice patch but pain still keeps persisting. Didn't have any back pain before the flu shot. Next day morning around 6 am had a vomiting sensation with so much sweat and throat was also not good. But I had so much pain in my upper left hand when flu shot was being given and may be it trigerred an upper back pain on left side.
patient stated that location swelled up "like a baseball" right after she recieved it and hurt/was sensitive to touch. she iced it and eventually the swelling went down but the pain has since remained. she states the pain is less but present.
very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient got very sick after receiving a dose of Shingrix. Limited demographics and information were provided by the reporter as she was irate and disconnected the call. The reporter did not consent to follow-up.
I went to the doctor for a wellness check and they sent me for a CT scan of my lungs for just checking because I am a smoker. The scan showed spots in both lungs, 1 nodule in each lung but everything else seemed fine.
Flu like symptoms, cold chills, nausea, redness in arm from point of injection traveling down to the elbow as days progressed, warm to the touch at injection site, chest pains on the left side, could not lift arm for 3 days
Patient did not present symptoms or adverse reaction. He was given booster doses from Pfizer and was not of age.
Pt experienced a syncopal episode which prompted a hospital visit on 7/12/21. Pt tested negative by PCR for COVID-19 on 7/18/21 and positive by PCR for COVID-19 on 7/24/21. Pt passed away on 7/28/21.
VS: 113/62-57-97.9-99%RA. Resident called clinic reporting rash to arm and body. No s/sx of distress noted. Remains alert and oriented to person, place, time, and situation. Speech clear and coherent, able to follow instructions appropriately. Resident denies SOB or difficulty breathing. Breathing even and non-labored. SpO2: 99%RA. Noted rash to left upper arm and bilateral sides of upper body from the waist to chest.  No rash noted to anterior chest. No swelling or elevation of rash noted. Denies pain to LUA. Able to perform full ROM. Resident stated he has allergies to bee stings, statins, and contrast dyes. Denies hx of anaphylactic shock. He reported he received his vaccine at 1330. Denied any ASE within 15 min after receiving vaccine.
Patient experiences fever over 100, T-max unknown, arthralgias, fatigue, and severe headache. Patient did not require medical treatment. Patient was unable to come to work as a result of condition which was treated with bedrest and over the counter ibuprofen.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Vomiting-Medium, Additional Details: after 15mins pt vomited while walking out of store. she came back and stated she felt dizzy she was very pale. b/p was 88/86 pulse 107. had pt sit for 5 more mins. went out again and bp was 89/79 pulse 95. contacted ambulance as pt still felt faint. ambulance came 15 mins later. by that time pt had drank a whole bottle of water. pts vitals were within range. emts recommended she seek a physicians help at urgent care.
Pt reports swelling redness, pain and itching at site - today still red and painful.
hives, scattered over body itchy hands and feet headache fever chills all over body/muscle ache fatigued sleeplessness
The room was spinning; drowsy...off balance; disoriented unable to speak; stomach felt awful;
headaches; arm was sore, red, and feverish; arm was sore, red, and feverish; arm was sore, red, and feverish; arm itched; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headaches), PYREXIA (arm was sore, red, and feverish), VACCINATION SITE ERYTHEMA (arm was sore, red, and feverish), VACCINATION SITE PAIN (arm was sore, red, and feverish) and VACCINATION SITE PRURITUS (arm itched) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), PYREXIA (arm was sore, red, and feverish), VACCINATION SITE ERYTHEMA (arm was sore, red, and feverish), VACCINATION SITE PAIN (arm was sore, red, and feverish) and VACCINATION SITE PRURITUS (arm itched). At the time of the report, HEADACHE (headaches), PYREXIA (arm was sore, red, and feverish), VACCINATION SITE ERYTHEMA (arm was sore, red, and feverish), VACCINATION SITE PAIN (arm was sore, red, and feverish) and VACCINATION SITE PRURITUS (arm itched) outcome was unknown. Not Provided          No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Pt received Hep A #2 in lt upper arm, 1-2 min later he looked pale, dizzy. His mother hold him prevented him from falling on the floor, patient lay down on the bed he started to shake (mild convulsion) x few second he received water, candy he relaxed after 5 minutes.
Saturday, August 28, 2021 at approximately 9:39am a male customer, 17 years of age, was administered a first Pfizer vaccine.  At 9:42 the customer stopped talking, leaned back in his chair suddenly, becoming stiff in the arms/legs, his eyes rolled in the back of his head/only last for seconds.  His airway was never compromised.  The 17 year old male was sweating, flushed, and had nausea.  He never lost consciousness other than the few seconds I just described (he was not alert).  He remained sitting in his chair, refused to get into a laying position.  At 9:43am I administered 25mg of liquid Benadryl.  At 9:44am his blood pressure was 82/53, pulse 75, 9:45am 110/66, pulse 85, 9:50am 122/78, pulse 89.  He was feeling better at this time, but left via ambulance.  According to the guardian he was given I.V. fluids at the hospital and later released.
Presented to hospital for SOB, fatigue. Required oxygen, IV steroids, and remdesivir. Discharged home with recommendation for sleep study.
Dizziness, possibly mild vertigo, shortly after the vaccination shot No other symptoms to suggest vasovagal or allergic reaction. Symptoms resolved on their own after about 5 minutes. VS stable throughout.   Initial BP - 143/71, Pulse - 59, O2 sat 99%. No orthostasis . Discharged to home.
patient received an incorrect does of pfizer, He received a teen dose of 0.3ml instead of a correct pedi dose of 0.2ml. the error was noted almost immediately and patient was observed for 30+ mins following the vaccination.  Parent was advised about all potential reactions by nursing director and vax team members.  Parents were encourged to call us with concerns 24/7 and were assured that a provider is on call.  Parent also advised that nusing will contact them in the AM (12/17) to follow up.  Nursing reached out to parent 9:43Am today 12/17 and we are waiting on a response.
side effects; low-grade fever; lethargy; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a week after receiving Shingrix, the patient experienced adverse drug reaction, low grade fever and lethargy. On an unknown date, the outcome of the adverse drug reaction, low grade fever and lethargy were unknown.   It was unknown if the reporter considered the adverse drug reaction, low grade fever and lethargy to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix saturday morning and experienced common side effect with low-grade fever and some lethargy.
Information has been received from a physician concerning a 17 year old male patient with no drug reactions/allergies and with no pertinent medical history who on 20-DEC-2011, was vaccinated with the first dose of GARDASIL (0.5 ml, IM, lot number: 668819/0477AA, exp. date: 29-JUN-2013) in the left arm. There was no concomitant medication. It was reported that on 20-DEC-2011, within one minute of administration of his first dose of GARDASIL the patient experienced syncope, seizure- like activity, dilated pupils, pale, stiffness and shaking. The patient sought medical attention via office visit. There was no treatment given for AE. On 20-DEC-2011, the patient recovered from syncope, seizure-like activity, dilated pupils, pale, stiffness and shaking. No lab diagnostic studies were performed. Upon internal review, seizure- like activity was considered to be an other medical event. Additional information has been requested.
Pt developed severe chicken pox post exposure to 1 yr old grandson just immunized for chicken pox. Pt on steroids and Methotrexate for Rheum Arth, Recipient of Enbrel 1 yr ago. Pneumonia. The follow up states "please code as secondary transmission."
5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program from a non-contactable consumer. This consumer reported same event for 5 patients. This is the 3rd of 5 reports.  A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer stated during conversation that 5 people she knew were vaccinated and died. She did not have any other information. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451919 same reporter/drug/event, different PTs; Reported Cause(s) of Death: 5 people she knew were vaccinated and died
DEVELOPED TEMP OF 100.4, KNOT IN RIGHT ARM WITH A LOT OF REDNESS AND TENDER TO TOUCH, SORENESS IN RT AXILLARY AREA ON 10/21/05. WAS TOLD TO KEEP TAKING HER BENADRYL. PRESENTED TO OFFICE 10/24/05 WITH NORMAL TEMP, 5.6 CM RED INDURATED AREA OR RT ARM. WAS TOLD TO ROTATE WARM COMPRESSES AND COLD PACKS OVER NEXT 24-48 HOURS AND TAKE BENADRYL 25 TID FOR NEXT 3 DAYS. ANTIBIOTIC FOR 7 DAYS. ON 10/26/05 AREA REMAINS RED WITH 1-1.5CM BLISTERS WITH SEVERAL SMALLER BLISTERS. ENTIRE AREA IS ABOUT 3.5"X6".
Developed a fever of 101 12 hours post vaccine administration along with other symptoms. Took Tylenol at 03:20 am with improvement in symptoms. Fever up 100.7 persisted after Tylenol wore off along with myalgias. No other symptoms beyond what was listed. Employee Health was contacted. chills, fatigue, fever, headache, injection site pain and new or worsened muscle pain
DID NOT SLEEP; FEELING HOT; This spontaneous report received from a vaccine facility concerned a 42 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included unspecified medical history from military service. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 31-MAR-2021, the subject experienced did not sleep. On 31-MAR-2021, the subject experienced feeling hot. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep on 01-APR-2021 and the outcome of feeling hot was not reported. This report was non-serious.
chills, fever, body aches, headache, weakness, thirst, overall body pain for 8 hours. Took aspirin and water,  very little relief.
Twenty three days of continuous headaches, extreme in nature that did not respond to Ibuprofen or acetaminophen.
Starting around 5 pm on July 17, noticed muscle aches along entire side of left body, including left leg. Left arm was aching. Around 5:00 am on July 18, woke up with mild fever, aches, decreased appetite, and head ache.  Also, a raised, red, very warm patch of skin on left upper arm appeared near injection site.  The patch was about 1" wide and 2" long.  All other symptoms were gone by July 19, except the skin reaction on upper left arm.  The skin remained red and very warm for several days, and returned to 'normal' by July 24.